BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK

    MDR report key: 1900617 · Received November 16, 2010

    Report

    Report Number
    6000001-2010-04914
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)ADDITIONAL INFORMATION: 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. 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). ADDITIONAL NARRATIVE: ONE USED UNIT WAS RECEIVED BY BAXTER FOR EVALUATION. TO VERIFY THE REPORTED CONDITION, A LEAK TEST WAS PERFORMED BY REFILLING THE DEVICE WITH COLORED WATER. AFTER FILLING, A LEAK WAS DETECTED AT THE INFUSOR'S PATIENT CONTROL MODULE (PCM) LUER. NO OTHER SOURCE OF LEAK WAS FOUND ON THE DEVICE. EXAMINATION OF THE INFUSOR'S PCM LUER REVEALED THE CAUSE OF LEAK TO BE AN OVER-MOLDING ISSUE. THE INNER SURFACE OF THE LUER HAS A SMALL OVER-MOLDED AREA THAT CAUSED THE LEAK. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) BASAL/BOLUS INFUSOR WAS OBSERVED LEAKING AFTER FILLING. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH BUPIVACAINE HYDROCHLORIDE AND THE LEAKAGE WAS OBSERVED AROUND THE LUER LOCK CONNECTION. THE BLUE WINGED CAP WAS FASTENED. THERE IS 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 BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H015

    Patients

    Seq Age Sex Outcome Treatment
    1