BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTOMERIC PUMPS

    MDR report key: 5190095 · Received October 29, 2015

    Report

    Report Number
    2026095-2015-00303
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Report Date
    October 1, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICES WERE REPORTED NOT TO BE RETURNING FOR ANALYSIS. A MODEL AND LOT NUMBER WERE REPORTED THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. RESULTS: 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. THE DEVICES WERE UNAVAILABLE FOR TESTING; THEREFORE, RESULTS ARE UNAVAILABLE. CONCLUSION: THE DEVICES WERE REPORTED TO BE FILLED TO 240MLS, THE NOMINAL FILL VOLUME FOR THIS DEVICE IS 270MLS. THE INSTRUCTIONS FOR USE (IFU) PROVIDE A CAUTION IN THE DELIVERY TIME TABLE. FILLING THE PUMP LESS THAN THE LABELED (NOMINAL), VOLUME RESULTS IN FASTER FLOW RATE. FILLING THE PUMP GREATER THAN THE LABELED (NOMINAL), VOLUME RESULTS IN SLOWER FLOW RATE. THE FLOW RATE MAY BE HIGHER OR LOWER THAN ±15% AT THE START AND END OF INFUSION. THERE ARE SEVERAL FACTORS THAT MAY AFFECT THE FLOW RATE OF THIS PUMP, SUCH AS FILL VOLUME, TEMPERATURE, VISCOSITY OF THE DRUG SOLUTION, PUMP POSITION, STORAGE TIME AND EXTERNAL PRESSURE. ALSO THE FLOW RESTRICTOR, WE DO NOT KNOW IF THE FLOW RESTRICTOR WAS TAPED TO THE PATIENT¿S SKIN. ACCORDING TO THE DFU, "TEMPERATURE WILL AFFECT SOLUTION VISCOSITY, RESULTING IN SHORTER OR LONGER DELIVERY TIME. THE PUMPS FLOW RESTRICTOR (LOCATED DISTAL TO THE FILTER) SHOULD BE CLOSE TO, OR IN DIRECT CONTACT WITH THE SKIN (31°C/88°F) AND THE TUBING SHOULD BE UNDER THE PATIENT¿S CLOTHING. IF THE PUMP IS USED WITH THE FLOW RESTRICTOR AT ROOM TEMPERATURE (20°C/68°F), DELIVERY TIME WILL INCREASE APPROXIMATELY BY 25%." ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS CASE. SHOULD ADDITIONAL INFORMATION PERTINENT TO THIS CASE BE RECEIVED, HALYARD WILL SUBMIT A SUPPLEMENTAL REPORT. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT REPORTING SYSTEMS FOR MONITORING, TRACKING AND TRENDING PURPOSES. NOT RETURNED TO MFG.

    Description of Event or Problem · 1

    {PLEASE REFERENCE REPORT NUMBERS 2026095-2015-00280 THRU 2026095-2015-00303 FOR (B)(4)}. REPORT 25 OF 25: IT WAS REPORTED BY OUR FOREIGN DISTRIBUTOR THAT THERE WERE APPROXIMATELY 20-25 PUMPS THAT RAN FASTER THAN EXPECTED. THERE WAS NO SPECIFICS PROVIDED ON THE EVENT DATES NOR PATIENTS. THEY WERE USED FOR CHEMOTHERAPY TREATMENT, AND THEY REPORTEDLY RAN DRY 10 TO 12 HOURS BEFORE THE EXPECTED TIMEFRAME. FURTHER DESCRIBED AS ¿THE MASSIVE APPLICATION DEVIATION, UNDERSHOT RUNTIME MASSIVELY, CLEARLY 10 - 12 HOURS HAS RUN EMPTY BEFORE THE SCHEDULED TIME OF APPLICATION. THE 5FU MEDICATION IS CONCENTRATION OF 2500 - 6000 MG / PUMP. THE APPROXIMATELY 20 -25 PUMPS WERE FILLED WITH 240 ML RESOLVED 5FU. THE 5FU WAS DISSOLVED WITH NACL 0.9%. THE PUMPS WERE NOT PLACED UNDER THE DUVET. THEY WERE ALL MOBILE PATIENTS AND THEY PUT THE PUMPS AT NIGHT ON THE NIGHTSTAND. UNFORTUNATELY WE HAVE NOT RECEIVED ANY SAMPLES." NO ADVERSE EVENTS OR MEDICAL INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718902 ELASTOMERIC PUMPS HOMEPUMP C-SERIES: 270ML X 5ML/HR MEB HALYARD - IRVINE C270050 0201022128

    Patients

    Seq Age Sex Outcome Treatment
    1