BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP: LT 270-132: 270 ML, 2ML/HR

    MDR report key: 3727164 · Received February 27, 2014

    Report

    Report Number
    2026095-2014-00024
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Report Date
    September 27, 2013
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS NOT RETURNED FOR AN EVAL AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED. THE DIRECTIONS FOR USE (DFU) WERE EVALUATED WITH THE REPORTED USER CONDITIONS. RESULTS: BASED ON THE DHR REVIEW, THERE WERE NO NCRS OR REWORKS DURING PRODUCT MFR ASSO. WITH THE REPORTED CONDITION. THE PRODUCTION LOT MET ALL MFR AND QUALITY SPECIFICATIONS. THERE IS NO EVIDENCE THAT THE CUSTOMER DID NOT FOLLOW THE DFU. THE PUMP WAS USED IMMEDIATELY AFTER FILLING. IN THE QUESTIONNAIRE RECEIVED FROM THE COMPLAINANT, THE PUMP WAS PLACED UNDER A BLANKET OR CLOTHING DURING USE. THIS MAY INDICATE THAT THE PUMP WAS INFUSED UNDER HIGHER TEMPERATURE. CONCLUSIONS: NO FILL VOLUME WAS PROVIDED, THEREFORE, AN ACTUAL INFUSION TIME CANNOT BE EVALUATED. BASED ON THE DFU, FLOW RATE COULD INCREASE IN AN ENVIRONMENT OF HIGH TEMPERATE. THE ASSIGNABLE CAUSE OF THE "FAST FLOW" IS UNK. WHEN FILLED TO NOMINAL VOLUME, EASYPUMP LT FLOW RATE ACCURACY IS +15% OF THE LABELED FLOW RATE WHEN INFUSION IS STARTED 0-8 H AFTER FILL AND DELIVERING NORMAL SALINE AS THE DILUENT AT 31 C DEGREE/ 88 DEGREE F AGAINST A BACK PRESSURE OF 40 CM OF WATER. THE DEVICE WAS NOT RETURNED TO I-FLOW FOR EVAL, THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. THIS INCIDENT HAS BEEN INCLUDED IN OUR COMPLAINT HANDLING DATABASE, WHICH WE ACTIVELY MONITOR AND TREND. BASED ON THIS INVESTIGATION THE COMPLAINT DISPOSITION IS UNABLE TO EVALUATED.

    Description of Event or Problem · 1

    DRUG/DILUENT: 5FU + NACL. FILL VOLUME: UNK, ANP. FLOW RATE: 2 ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: IV INFUSION. ACCELERATED INFUSION WITH CODE: (B)(4). INFUSION IN 120 HOURS INSTEAD OF 132 HOURS. (B)(4). PT DID NOT EXHIBIT ANY DRUG RELATED SYMPTOMS. NO MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122110 EASYPUMP: LT 270-132: 270 ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. 04434376 0200910952

    Patients

    Seq Age Sex Outcome Treatment
    1 ANP PUMP CONNECTED TO PICC