BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.5ML PATIENT CONTROL MODULEJAPAN

    MDR report key: 1911111 · Received November 30, 2010

    Report

    Report Number
    6000001-2010-05332
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: ONE USED SAMPLE WAS RECEIVED. UPON SAMPLE RECEIPT, WHITE DRUG RESIDUE WAS NOTED WITHIN THE HOUSING OF THE DEVICE. VISUAL EXAMINATION OF THE DEVICE SHOWED NO SIGNS OF PHYSICAL DAMAGE OR ABNORMALITY. A LEAK TEST WAS SUBSEQUENTLY PERFORMED BY FILLING THE RESERVOIR WITH GREEN WATER. DURING FILL, NO SIGNS OF LEAK WERE OBSERVED. AFTER FILL, THE BUTTON WAS MANUALLY PRESSED (GENTLY AND ALSO VERY HARD) FOR FLOW. NO SIGNS OF LEAK WERE OBSERVED AFTER PRESSING THE BUTTON. AFTER FILLING WITH GREEN WATER, THE DEVICE WAS ALSO BEING MONITORED FOR 24 HOURS FOR ANY SIGNS OF LEAK. AFTER 24 HOURS, NO SIGNS OF LEAK WERE FOUND ANYWHERE IN THE DEVICE. THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE NOT IDENTIFIED. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) PATIENT CONTROL MODULE, USED WITH A BASAL/BOLUS INFUSOR DEVICE, WAS OBSERVED LEAKING RIGHT AFTER PATIENT USE. THE DEVICE WAS FILLED WITH MORPHINE HYDROCHLORIDE AND NORMAL SALINE. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.5ML PATIENT CONTROL MODULEJAPAN PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09M056

    Patients

    Seq Age Sex Outcome Treatment
    1