BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 100, 48 PACK,50125

    MDR report key: 2013236 · Received March 10, 2011

    Report

    Report Number
    6000001-2011-01757
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: ONE SAMPLE WAS RECEIVED FOR EVALUATION BY BAXTER. THE REPORTED CONDITION OF "BROKEN OFF NEAR THE LUER LOCK/BLUE WINGED CAP JUNCTION" WAS CONFIRMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER HEALTHCARE THAT THE TUBING OF ONE (1) CE INTERMATE SV100 DEVICE HAD BROKEN OFF NEAR THE LUER LOCK/BLUE WINGED CAP JUNCTION AFTER PATIENT USE. ACCORDING TO THE REPORT, THE PATIENT CONNECTED TO THE DEVICE FOR THERAPY, OBSERVED THE DEVICE LEAKING NEAR THE LUER LOCK, DISCONNECTED THE DEVICE AND THEN RÉSUMÉ THE DEVICE TO THE PHARMACY. UPON RECEIPT OF THE SAMPLE AT THE PHARMACY, THE CUSTOMER STATED THE TUBING HAD BROKEN OFF NEAR THE LUER LOCK CAUSING THE DEVICE TO LEAK. THE DEVICE WAS FILLED WITH 100ML OF NORMAL SALINE. THE DEVICE WAS THEN SENT TO THE CUSTOMER WITH A 10ML VIAL OF AZATHIOPRINE. THE PATIENT WAS INSTRUCTED TO INJECT THE 10ML OF THE DRUG INTO THE DEVICE PRIOR TO CONNECTION FOR THERAPY. THERE WAS 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 CE INTERMATE SV 100, 48 PACK,50125 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10N055

    Patients

    Seq Age Sex Outcome Treatment
    1 AZATHIOPRINE| NORMAL SALINE