BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGPN,270X5,PBI-AM,-,OQI,5

    MDR report key: 5076172 · Received September 14, 2015

    Report

    Report Number
    2026095-2015-00232
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 24, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ACTUAL DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION. A VISUAL OBSERVATION, FLOW RATE ACCURACY TEST, INFUSION VERIFIED AND PRESSURE POT TEST WERE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. RESULTS: THE PUMP WAS REFILLED WITH 0.9% OF SALINE TO THE NOMINAL VALUE OF 270ML. INFUSION WAS VERIFIED AND THE FLOW ACCURACY TEST WAS PERFORMED. AFTER 40.5 HOURS OF TESTING, THE PUMP YIELDED A FLOW RATE OF 4.61ML/HR, WHICH IS WITHIN SPECIFICATIONS WITH A +/-15% TOLERANCE. THE PRESSURE POT WAS PERFORMED WITHOUT THE FILTER. THE TUBING WAS DETACHED FROM THE PUMP AND CONNECTED TO A PRESSURE GAUGE. THE AVERAGE BLADDER PRESSURE USED WAS 9.81PSI. THE FLOW RESTRICTOR YIELDED A FLOW RATE OF 4.84ML/HR, WHICH IS WITHIN SPECIFICATIONS WITH A +/-15% TOLERANCE. THE INVESTIGATION SUMMARY CONCLUDES THAT FAST FLOW WAS NOT OBSERVED. DURING THE FLOW ACCURACY TEST, THE PUMP MET SPECIFICATIONS. DURING PRESSURE POT TESTING, THE FLOW CONTROL TUBING MET SPECIFICATIONS USING THE AVERAGE BLADDER PRESSURE. CONCLUSION: THE SAMPLE EVALUATION CONCLUDED THAT FAST FLOW WAS NOT OBSERVED. AS THE DEVICE ANALYSIS CANNOT DETERMINE THE ROOT CAUSE OF THE FLOW ISSUE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE (IFU) THERE ARE SEVERAL FACTORS THAT MAY AFFECT THE FLOW RATE INCLUDING FILL VOLUME, TEMPERATURE, VISCOSITY OF THE DRUG SOLUTION, PUMP POSITION, STORAGE TIME AND EXTERNAL PRESSURE. IT IS NOTED THAT THE PUMP WAS USED IN CLOSE PROXIMITY TO A HEAT BLANKET THAT GETS "QUITE HOT" AND THIS COULD HAVE CONTRIBUTED TO THE INCIDENT. THE DHR WAS REVIEWED FOR THE LOT NUMBER OF THE MANUFACTURED UNIT. THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEVICE WAS RECEIVED FOR ANALYSIS AND TESTING, THE LOT NUMBER WAS RETRIEVED FROM THE RETURNED UNIT. THEREFORE, THE DEVICE HISTORY REVIEW (DHR) IS IN PROGRESS. RESULTS: EVALUATION AND INVESTIGATION RESULTS WILL BE PROVIDED ONCE THEY ARE COMPLETED. CONCLUSION: TESTING IS CURRENTLY IN PROGRESS AND PENDING COMPLETION; THEREFORE, INVESTIGATION OF THE INCIDENT AND DEVICE ARE ON-GOING. ONCE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM.

    Description of Event or Problem · 1

    FILL VOLUME: 270 ML. FLOW RATE: 5 ML/HR. IT WAS REPORTED THAT A NURSE NOTICED A PAIN PUMP EMPTIED AFTER 15 HOURS; ALSO, A HEATING BLANKET WAS IN USE AT THE TIME OF THERAPY. THE PUMP IS REPORTED TO BE AVAILABLE FOR RETURN, AND THERE WAS NO REPORT OF PATIENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605843 SURGPN,270X5,PBI-AM,-,OQI,5 ON-Q PAINRELIEF SYSTEM INT'L: SOAKER 5IN: 270 ML X 5 ML/HR MEB HALYARD - IRVINE PS12504 0202162823

    Patients

    Seq Age Sex Outcome Treatment
    1