BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3802309 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14906
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K884505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE LOT WAS MANUFACTURED FROM SEPTEMBER 14, 2012 TO SEPTEMBER 17, 2012. EVALUATION SUMMARY: VISUAL INSPECTION WAS PERFORMED AND DID NOT IDENTIFY ANY EVIDENCE OF A RUPTURED BLADDER. A FUNCTIONAL TEST WAS THEN PERFORMED IN WHICH THE BLADDER WAS REFILLED WITH COLORED WATER; AGAIN NO EVIDENCE OF A RUPTURED BLADDER WAS FOUND DURING OR AFTER FILLING. THE REPORTED CONDITION WAS NOT IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, AN UNRELATED FAILURE WAS FOUND WHICH WILL BE CAPTURED AND REPORTED IN (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A BASAL/BOLUS INFUSOR RUPTURED. THIS OCCURRED BEFORE PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280975 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12J021

    Patients

    Seq Age Sex Outcome Treatment
    1