BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK

    MDR report key: 2032142 · Received March 28, 2011

    Report

    Report Number
    6000001-2011-02275
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 7, 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: THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT INCIDENT FOR MISSING FILL PORT WAS CONFIRMED. THE PROCESS OF PLACING THE FILLPORT ON THE FILLING CAP IS A MANUAL MANUFACTURING PROCESS. THIS TYPE OF DEFECT WAS ADDRESSED IN THE DEFECT AWARENESS TRAINING TO ALL APPLICABLE PERSONNEL. A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) BASAL/BOLUS INFUSOR DEVICE WAS OBSERVED MISSING A FILL PORT CAP WHEN THE OVERPOUCH WAS OPENED. THIS REPRESENTS A BREACH IN THE STERILE FLUID PATHWAY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H046

    Patients

    Seq Age Sex Outcome Treatment
    1