BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4200821 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37361
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED FROM MARCH 5, 2014 TO MARCH 6, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION FLUID WAS OBSERVED WITHIN THE OVERPOUCH DUE TO THE BLUE WINGED LUER CAP BEING LOOSE. THIS FLUID ALSO HAD ENTERED INTO THE HOUSING THROUGH THE COIL CAP WHICH IS NOT LEAK PROOF. A FUNCTIONAL LEAK TEST WAS PERFORMED BY FILLING THE DEVICE WITH WATER AND TIGHTENING THE BLUE WINGED LUER CAP. THE NEXT DAY, NO LEAKS WERE NOTED FROM THE DEVICE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME MULTIRATE INFUSOR LEAKED DURING INFUSION. THE REPORTER STATED THAT SOLUTION LEAKED INTO THE HOUSING. THE DEVICE WAS FILLED WITH UNKNOWN ANTIBIOTICS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679795 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14C004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ANTIBIOTICS