BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES: 270ML, 5ML/HR

    MDR report key: 4286223 · Received November 7, 2014

    Report

    Report Number
    2026095-2014-00222
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 9, 2014
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICES WERE REPORTED TO BE UNAVAILABLE FOR RETURN AND ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. RESULTS: AS A DEVICE WAS NOT AVAILABLE FOR AN EVAL NO METHODS WERE PERFORMED, THEREFORE RESULTS CANNOT BE OBTAINED. THE DHR WAS REVIEWED FOR THE LOT NUMBER OF THE MANUFACTURED UNIT. THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCR'S) FOR THIS LOT. THE LOT MET THE PROCESS SPECS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. A REVIEW OF THE USE CONDITIONS AND THE INSTRUCTIONS FOR USE (IFU) WAS PERFORMED AND ACCORDING TO THE FLOW TABLE ON THE IFU 14-60-591-0-03. THIS PUMP MODEL FILLED TO 244ML'S WILL COMPLETE INFUSION IN ABOUT 48 HOURS WITH A TOLERANCE OF +/-15%. THEREFORE THE APPROXIMATE INFUSION TIME FOR 244ML'S WILL BE BETWEEN 40.8 HOURS AND 55.2 HOURS, THE IFU ALSO STATED "FILLING THE PUMP LESS THAN LABELED (NOMINAL) FILL VOLUME RESULTS IN FASTER FLOW RATE. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO I-FLOW FOR AN EVAL, THEREFORE WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. SHOULD ADD'L INFO BE RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFO IS USED TO IDENTIFY THE NEED FOR ADD'L INVESTIGATIONS.

    Description of Event or Problem · 1

    FILL VOLUME: 230ML. FLOW RATE: 5ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: CENTRAL LINE. REPORT 2 OF 3: PLEASE REF: 2026095-2014-00215/14-00892(A), 2026095-2014-00223/14-00892(C). INCIDENT #2, PT #2: IT WAS REPORTED BY A PHARMACY THAT THERE WERE THREE INCIDENTS OF FAST FLOW THAT OCCURRED IN THREE SEPARATE PTS. ALL THREE PUMPS WERE OF THE SAME MODEL AND LOT NUMBER, THEY WERE FILLED WITH 5-FU AND SALINE TO 230ML'S. THE PTS RECEIVED THE PUMPS AT THE INFUSION CENTER AND THEN WENT HOME WITH THEM. THE PTS CALLED TO REPORT THAT THE PUMPS HAD FINISHED EARLIER THAN EXPECTED. ALL PTS USED THE PUMPS VIA CENTRAL LINES. FOR INCIDENT TWO IT WAS REPORTED THAT THE PT'S PUMP WAS FILLED ON (B)(6) 2014, AND INFUSION BEGAN ON (B)(6) 2014. THE INFUSION WAS REPORTED TO HAVE ENDED ON (B)(6) 2014. THE PUMP WAS VISUALLY EMPTY AT THE TIME OF DISCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719646 HOMEPUMP C-SERIES: 270ML, 5ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. C270050 0201325987

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR DRUG: 5-FLUOROURACIL IN NORMAL SALINE| CONCENTRATION: 21.4 MG/DL