BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2122628 · Received June 14, 2011

    Report

    Report Number
    6000001-2011-07624
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK CONDITION WAS NOT CONFIRMED DUE TO SAMPLE UNAVAILABILITY. COMPLAINT SAMPLE WAS NOT AVAILABLE, A PHYSICAL EVALUATION OF THE REPORTED CONDITION COULD NOT BE CONDUCTED, THEREFORE NO DEFINITIVE CONCLUSION CAN BE REACHED IN REGARDS TO CONFIRMATION OF THE REPORTED COMPLAINT CONDITION. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL OF THE ACCEPTANCE CRITERIA FOR RELEASE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE RESULTS OF EVALUATION COULD NOT BE COMPLETED AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS PERFORMED WHICH FOUND NO NONCONFORMANCES.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN UNKNOWN QUANTITY OF BAXTER INTERMATES SV200 SHOWED LEAKAGES AT THE LEVEL OF THE DISTAL LUER LOCK. DURING THE PAST FEW WEEKS, SEVERAL UNITS SHOWED LEAKAGE AFTER THE FILLING STEPS PRIOR TO BE CONNECTED TO THE PATIENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, MEDICAL INTERVENTION. NO SAMPLE AVAILABLE. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10M009

    Patients

    Seq Age Sex Outcome Treatment
    1