BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV7, 12 PACK

    MDR report key: 1880586 · Received October 22, 2010

    Report

    Report Number
    6000001-2010-04445
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "LEAK" WAS CONFIRMED DUE TO A PINCH IN THE TUBING. THE CAUSE OF THE PINCH WAS DUE TO IMPROPER PLACEMENT OF THE TUBING DURING THE PACKAGING OPERATION BY THE MANUFACTURING PERSONNEL. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR LV 7 DEVICE WAS FOUND TO BE LEAKING. THEREFORE, THE STERILE FLUID PATHWAY WAS BREACHED. THIS CONDITION WAS DISCOVERED AFTER THE DEVICE WAS FILLED WITH A 220 ML SOLUTION OF NAROPEINE, CATAPRESSAN, AND SODIUM CHLORIDE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV7, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09C042

    Patients

    Seq Age Sex Outcome Treatment
    1