BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGPN,270X10,HMPMPC,-,LFR-CS,10

    MDR report key: 5142319 · Received October 10, 2015

    Report

    Report Number
    2026095-2015-00245
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    August 30, 2015
    Report Date
    September 14, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION MADE FOR CORRECT REFERENCE MFG. REPORT NUMBER. (B)(4). METHOD: THE DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL INSPECTION, PRESSURE TESTING, FLOW TESTING AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WERE PERFORMED. PUMP #2 WAS REFILLED WITH 0.9% OF SALINE USING THE REPEATER PUMP TO THE NOMINAL VALUE OF 270ML. INFUSION WAS VERIFIED AND THE FLOW ACCURACY TEST WAS PERFORMED. AFTER 20.25 HOURS OF TESTING, THE PUMP YIELDED A FLOW RATE OF 8.44ML/HR, WHICH IS BELOW SPECIFICATIONS WITH A +/-15% TOLERANCE. THE PRESSURE POT WAS PERFORMED ON THE FLOW RESTRICTOR WITHOUT THE FILTER. THE TUBING WAS DETACHED FROM THE PUMP AND CONNECTED TO A PRESSURE GAUGE. THE AVERAGE BLADDER PRESSURE USED WAS 10.43PSI. THE FLOW RESTRICTOR YIELDED A FLOW RATE OF 9.64ML/HR, WHICH IS WITHIN SPECIFICATIONS WITH A +/-15% TOLERANCE. CONCLUSION: THE INVESTIGATION SUMMARY CONCLUDES THAT FAST FLOW WAS NOT OBSERVED FOR PUMP #2. DURING THE FLOW ACCURACY TEST, THE PUMP WAS BELOW SPECIFICATIONS. DURING PRESSURE POT TESTING, THE FLOW CONTROL TUBING MET SPECIFICATIONS USING THE AVERAGE BLADDER PRESSURE. 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. 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: AT THE TIME OF THIS REPORT THE DEVICE WAS REPORTED TO BE RETURNING FOR ANALYSIS. WE ARE CURRENTLY PENDING THE RECEIPT OF THE DEVICE; HOWEVER, PHOTOGRAPHIC IMAGES WERE PROVIDED TO REVIEW. AT THIS TIME, THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROGRESS FOR THE LOT NUMBER PROVIDED. RESULTS: THE INVESTIGATION IS CURRENTLY IN PROGRESS. ONCE THE DEVICE IS RECEIVED, TESTING WILL BE PERFORMED AND RESULTS WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED. CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. DEVICES ARE EN-ROUTE TO MANUFACTURER.

    Description of Event or Problem · 1

    PLEASE REFERENCE 2026095-2015-00903 FOR INCIDENT 1 OF 2.

    Description of Event or Problem · 1

    INCIDENT 2 OF 2, PLEASE REFERENCE TO 2026095-2015-00244(A). IT WAS REPORTED BY OUR FOREIGN DISTRIBUTOR THAT AN INCIDENT OF FASTER FLOW OCCURRED TWICE. FURTHER DESCRIBED AS "INFUSION ENDED 4 HOURS EARLIER AND IT HAPPENED TWICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672908 SURGPN,270X10,HMPMPC,-,LFR-CS,10 HOMEPUMP C-SERIES: 270ML, 10ML/HR MEB HALYARD - IRVINE C270100-10 0202089250

    Patients

    Seq Age Sex Outcome Treatment
    1