BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2110858 · Received June 2, 2011

    Report

    Report Number
    6000001-2011-06960
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHOTO EVALUATION CONFIRMED A RUPTURED BLADDER IN A FOOTED POSITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. A (B)(4) WAS INITIATED TO ADDRESS THE ROOT CAUSE INVESTIGATION OF THE BLADDER RUPTURE ISSUE. LABELING REVIEW WAS NOT CONDUCTED. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) LV250 INTERMATE RUPTURED DURING PATIENT USE. THE DEVICE WAS FILLED WITH MEROPENEM IN SODIUM CHLORIDE 0.9%. THE DEVICE HAD 1-2ML OF SOLUTION LEFT IN THE RESERVOIR WHEN THE RUPTURE OCCURRED. NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11B005

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| MEROPENEM