BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES 270ML, 5ML/HR

    MDR report key: 5004214 · Received August 14, 2015

    Report

    Report Number
    2026095-2015-00212
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 23, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL INSPECTION AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WERE PERFORMED. RESULTS: THERE ARE NO TESTING RESULTS AVAILABLE AS THE INVESTIGATION AND EVALUATION ARE CURRENTLY IN PROGRESS. HOWEVER, 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. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. CONCLUSIONS: ONCE THE ANALYSIS AND INVESTIGATION ARE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. 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

    METHOD: ACTUAL DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION. A FLOW RATE ACCURACY TEST 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 5.08ML/HR, WHICH IS WITHIN SPECIFICATIONS WITH A +/-15% TOLERANCE. THE PRESSURE POT WAS PERFORMED ON THE FLOW CONTROL TUBING WITHOUT THE FILTER. THE TUBING WAS DETACHED FROM THE PUMP AND CONNECTED TO A PRESSURE GAUGE. THE FLOW CONTROL TUBING YIELDED A FLOW RATE OF 4.80ML/HR, WHICH IS WITHIN SPECIFICATIONS WITH A +/-15% TOLERANCE. 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. 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.

    Description of Event or Problem · 1

    PLEASE REFERENCE: 2026095-2015-00203/15-00644(A). FILL VOLUME: 241ML, FLOW RATE: 5ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: IV PORT, INFUSION STARTED ON (B)(6) 2015 INFUSION ENDED ON (B)(6) 2015 IN THE PM. IT WAS REPORTED THAT THE INFUSION OF A PUMP FINISHED EARLIER THAN EXPECTED. THIS IS THE SECOND REPORTED INCIDENT FOR THE SAME PATIENT. THE INFUSION ENDED APPROXIMATELY 20 HOURS EARLIER THAN THE EXPECTED 46 HOURS. NO PATIENT INJURY WAS REPORTED. THE DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539926 HOMEPUMP C-SERIES 270ML, 5ML/HR ELASTOMERIC PUMP MEB HALYARD - IRVINE C270050 0201316743

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR