BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALF DAY INFUSOR, 5ML/HR 12PK

    MDR report key: 1760337 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-00843
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED AND CONFIRMED THE REPORTED CONDITION OF A RESERVOIR RUPTURE. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. THE ROOT CAUSE IS CURRENTLY BEING INVESTIGATED UNDER CAPA (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT THE TUBING AND ACCESS PORT OF A LAP-BAND WAS EXPLANTED AS "IT WAS DISCOVERED THAT THE LAP-BAND DEVICE WAS NOT HOLDING A FILL". A BARIUM SWALLOW WAS PERFORMED. THE DOCTOR EXPLANTED THE PORT AND NOTICED THAT "THE TUBING HAD FRACTURED". THE TUBING AND THE ACCESS PORT WERE REPLACED AND RETURNED TO ALLERGAN FOR PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF A HALF DAY INFUSOR RUPTURED DURING FILLING. THE RESERVOIR RUPTURED IMMEDIATELY AFTER FILLING OF AN UNKNOWN SOLUTION OF MEDICINE BEGAN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALF DAY INFUSOR, 5ML/HR 12PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10B024

    Patients

    Seq Age Sex Outcome Treatment
    1