BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2073290 · Received May 1, 2011

    Report

    Report Number
    6000001-2011-03313
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    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

    (B)(4). ADDITIONAL NARRATIVE: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. THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 80 ML OF SOLUTION IN THE RESERVOIR. VISUAL EXAMINATION OF THE UNIT CONFIRMED THAT THE LOWER FILM WRAP WAS MISSING. THE ROOT CAUSE OF THE MISASSEMBLED CONDITION WAS DUE TO OPERATOR ERROR DURING THE FILM WRAP ASSEMBLY PROCESS. AS A RESULT OF THIS INCIDENT, THE COMPLAINT SAMPLE WAS USED TO BRING AWARENESS TO ALL APPLICABLE MANUFACTURING OPERATORS. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. A BATCH REVIEW WAS PERFORMED AND NO NONCONFORMANCES WERE RELATED TO THE REPORTED CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) INFUSOR SV 2 DEVICE WAS MISSING FILM WRAP ON LOWER PART OF THE BLADDER. THIS WAS OBSERVED AFTER FILLING WITH SALINE, BEFORE PATIENT USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10M096

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE