Failure Modes and Effects Analysis
Total Page：16
File Type：pdf, Size：1020Kb
B62 Benedum Hall Failure Modes and Effects Analysis ECMOre Pittsburgh PA 15262 Doc. No. FMEA-002 Rev. 2 412-555-9873 Date: 04/16/04 Status: Final
Number: FMEA-002 Revision: 2 Title: Failure Modes and Effects Analysis UNCONTROLLED DOCUMENT UNLESS ISSUED WITH A RED STAMP This document is the confidential property of ECMOre and may not be reproduced without prior written consent.
Revision Approvals: Date Originator Desiree Bonadonna 04/16/2004 [Originating dept. approval] Bioengineering 04/16/2004 [Other dept. approval] Electrical Engineering 04/16/2004 Quality Assurance Laura Gilmour 04/16/2004 General Management Apryle Craig 04/16/2004 1.0 Purpose 1.1. Organizes potential failure modes and effects of those failures 2.0 Scope 2.1. Effects hazard analysis 3.0 References 3.1 FMT-001 3.2 FMEA-001 4.0 Failure Mode and Effects Analysis 5.0 Revision History 5.1. FMEA-001; Revision 1; 12/04/03 5.2. FMEA-002; Revision 2; 04/16/04 FINAL
FMEA-002 Page 1 of 6 B62 Benedum Hall Failure Modes and Effects Analysis ECMOre Pittsburgh PA 15262 Doc. No. FMEA-002 Rev. 2 412-555-9873 Date: 04/16/04 Status: Final
function or failure effect on risk user detection component mode system possible hazards index means applicable control
FMEA-002 Page 2 of 6 B62 Benedum Hall Failure Modes and Effects Analysis ECMOre Pittsburgh PA 15262 Doc. No. FMEA-002 Rev. 2 412-555-9873 Date: 04/16/04 Status: Final
Extreme Fluid dripping from Maintain reasonable Transducer Line Temperatures Crack Minor Leak 17 connector room temperature Extreme Positive blood Temperatures Crack Break Sterility 15 cultures Extreme Systematic checking of Temperatures Crack Pressure Drop 17 Pressure Alarm circuit Extreme Pressure Alarm, Temperatures Crack Disconnect-Major Leak 12 fluid Connector material able Extreme Pressure Alarm, to withstand wide Temperatures Expansion Disconnect-Major Leak 12 fluid temperature ranges Extreme No pressure output to Temperatures Melt monitor 17 Pressure Alarm Extreme Interruption of circuit Temperatures Melt flow 12 Pressure Alarm Incompatibility Research compatibility of material blood Adverse Patient of connector material with blood reaction Patient Allergy 10 Reaction before purchase Incompatibility of material blood Positive blood Test patient for material with blood reaction Rejection 8 cultures allergies Incompatibility of material blood with blood reaction Blood Clotting 8 Pressure alarm Maintain proper ACT's research current circuits Incompatibility unreliable Pressure Alarm, and ensure universal with circuit connection Disconnect-Major Leak 10 fluid connections Incompatibility Product Unable to fit with circuit useless No pressure readings 11 connector to tubing
Function or Failure Effect on Risk User Detection Component Mode System Possible Hazards Index Means Applicable Control
FMEA-002 Page 3 of 6 B62 Benedum Hall Failure Modes and Effects Analysis ECMOre Pittsburgh PA 15262 Doc. No. FMEA-002 Rev. 2 412-555-9873 Date: 04/16/04 Status: Final
Pressure Line Extreme Maintain reasonable Tubing Temperatures Crack Pressure Drop 17 Pressure Alarm room temperature Extreme No pressure output to Systematic checking of Temperatures Crack monitor 17 Pressure Alarm circuit Tubing material able to Extreme Interruption of withstand wide Temperatures Expansion pressure reading 12 Pressure Alarm temperature ranges Extreme Interruption of Temperatures Melt pressure reading 12 Pressure Alarm research current circuits unreliable Pressure Alarm, connections and Incompatibility connection Disconnect 18 pressure line fluid pressure transducers Unable to fit tubing to connector or into Product pressure and ensure universal Incompatibility useless No pressure readings 11 transducer connections Increase pressure line Maintain reasonable Kink pressure inaccurate reading 9 Pressure Alarm tubing length blood seen in tubing connecting choose transducer hole in transducer to approved for use in Transducer puncture diaphragm blood loss 12 pressure monitor ECMO circuit electrical incorrect calibration/set-up malfunction voltage inaccurate reading 12 unable to calibrate examination
Function or Failure Effect on Risk User Detection Component Mode System Possible Hazards Index Means Applicable Control Abnormal read-out No audible No attention drawn to without audible Audible Alarm short in wires alarm pressure deviations 15 alarm strain relief for wires rusted wiring No audible No attention drawn to 17 Abnormal read-out insulated wiring alarm pressure deviations without audible
FMEA-002 Page 4 of 6 B62 Benedum Hall Failure Modes and Effects Analysis ECMOre Pittsburgh PA 15262 Doc. No. FMEA-002 Rev. 2 412-555-9873 Date: 04/16/04 Status: Final
alarm
Abnormal read-out magnetic field No audible No attention drawn to without audible presence alarm pressure deviations 17 alarm protective enclosure Abnormal read-out Digital Pressure No digital unable to assess without audible Display short in wires display patient's wellbeing 15 alarm strain relief for wires Abnormal read-out No digital unable to assess without audible rusted wiring display patient's wellbeing 17 alarm insulated wiring Abnormal read-out magnetic field No digital unable to assess without audible presence display patient's wellbeing 17 alarm protective enclosure Abnormal read-out Visual and audible incorrect without audible alarm independent of short in wires readout possible misdiagnosis 15 alarm display Abnormal read-out incorrect without audible rusted wiring readout possible misdiagnosis 15 alarm Abnormal read-out magnetic field incorrect without audible presence readout possible misdiagnosis 15 alarm unable to discern Audible alarm but Visual and audible electrical No visual which pressure is out no visual alarm independent of Visual Alarm malfunction alarm of physiological range 15 distinction display
Function or Failure Effect on Risk User Detection Component Mode System Possible Hazards Index Means Applicable Control unable to discern Audible alarm but No visual which pressure is out no visual short in wires alarm of physiological range 15 distinction strain relief for wires unable to discern Audible alarm but No visual which pressure is out no visual rusted wiring alarm of physiological range 15 distinction insulated wiring
FMEA-002 Page 5 of 6 B62 Benedum Hall Failure Modes and Effects Analysis ECMOre Pittsburgh PA 15262 Doc. No. FMEA-002 Rev. 2 412-555-9873 Date: 04/16/04 Status: Final
unable to discern Audible alarm but magnetic field No visual which pressure is out no visual presence alarm of physiological range 15 distinction protective enclosure display shows does not value outside of save will not visually or physiological range Programmable electrical programmed audibly alarm when but no alarm goes alarm independent of Range malfunction range outside of range 15 off display display shows does not value outside of save will not visually or physiological range programmed audibly alarm when but no alarm goes short in wires range outside of range 15 off strain relief for wires display shows does not value outside of save will not visually or physiological range programmed audibly alarm when but no alarm goes rusted wiring range outside of range 15 off insulated wiring display shows does not value outside of save will not visually or physiological range magnetic field programmed audibly alarm when but no alarm goes presence range outside of range 15 off protective enclosure
FMEA-002 Page 6 of 6