BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE, 100ML, 100ML

    MDR report key: 2151272 · Received June 21, 2011

    Report

    Report Number
    2026095-2011-00167
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INFO PROVIDED FOR THIS INVESTIGATION REVEALED THAT BOTH PUMPS WERE USED PRIOR TO THE 4-HOUR WAITING PERIOD. THE DIRECTIONS FOR USE (DFU) (1303907, REV. D) CONTAIN A WARNING: "THE HOMEPUMP ECLIPSE MUST BE FILLED 4 HOURS PRIOR TO ADMINISTRATION TO INFUSE AT THE LABELED FLOW RATE. IF THE HOMEPUMP ECLIPSE IS USED IMMEDIATELY AFTER FILLING, FLOW RATE MAY INCREASE BY UP TO 50%." THE DFU ALSO STATES: "CAUTIONS: ACTUAL INFUSION TIMES MAY VARY DUE TO THE FOLLOWING: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE." RECEIVED TWO EMPTY, USED PUMPS FOR EVALUATION AND INVESTIGATION. THE VISUAL INSPECTION OF PUMP 1 OBSERVED THE CLAMP CLOSED. THE PUMP WAS FILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 100ML. WHEN THE PINCH CLAMP WAS OPENED, THE PUMP INFUSED. A FLOW RATE ACCURACY TEST WAS PERFORMED. PUMP 1 INFUSED WITHIN SPECIFICATION. THE VISUAL INSPECTION OF PUMP 2 OBSERVED THE CLAMP CLOSED. THE PUMP WAS FILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 100ML. WHEN THE PINCH CLAMP WAS OPENED, THE PUMP INFUSED. A FLOW RATE ACCURACY TEST WAS PERFORMED. PUMP 2 INFUSED WITHIN SPECIFICATION. CUSTOMER COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    DRUG/DILUENT: STERILE WATER. FILL VOLUME: 100ML AND 60ML. FLOW RATE: 100ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. FAST FLOW. FOLLOWING A COMPLAINT FROM A PT, PHARMACY TESTED TWO PUMPS FOR FLOW RATE, ONE FILLED TO 100ML AND ONE FILLED TO 60ML. AFTER FILLING, PHARMACY DID NOT WAIT THE 4 HOURS PRIOR TO TEST. THE 100ML PUMP INFUSED IN 37 MINUTES AND THE 60ML PUMP INFUSED IN LESS THAN 30 MINUTES. NO PT CONTACT. NO ADVERSE EVENT OCCURRED. THE PT DISCARDED THE PUMP. PT SUBSEQUENTLY COMPLETED ANTIBIOTIC THERAPY AND HAS BEEN DISCHARGED FROM THE HOME CARE SERVICE. PER DFU: NOMINAL FLOW RATE: 100 ML/HR. NOMINAL FILL VOLUME: 100ML. MAXIMUM FILL VOLUME: 125ML. THE INFUSION DELIVERY TIME IS 1 HOUR WHEN FILLED TO NOMINAL VOLUME AND FLOW RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP ECLIPSE, 100ML, 100ML ELASTOMERIC PUMP MEB I-FLOW CORPORATION E101000 0A2597

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR