BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV5, 12 PK

    MDR report key: 1841427 · Received September 22, 2010

    Report

    Report Number
    6000001-2010-03446
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    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). 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF AN INFUSOR LV 5 DEVICE WHICH WAS LEAKING FROM ITS RESERVOIR WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY MISSING FILM WRAP, STEMMING FROM THE DEVICE BEING INCORRECTLY ASSEMBLED DURING MANUFACTURING. THIS DEVICE IS A SINGLE USE DEVICE AND WILL BE DISCARDED. A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF AN INFUSOR LV 5 DEVICE DID NOT INFLATE AND LEAKED DURING FILLING. THEREFORE, THE STERILE FLUID PATHWAY WAS BREACHED. THE DEVICE WAS BEING FILLED WITH SALINE AT THE TIME OF THE RUPTURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) BASAL/BOLUS INFUSOR WAS OBSERVED LEAKING DURING PATIENT USE AT THE LOCATION OF THE Y-SITE OF THE TUBING DUE TO A PINHOLE. ACCORDING TO THE REPORT, THERAPY BEGAN AT 10:30AM AND AT 2:30PM A CALL WAS RECEIVED AT THE HOSPITAL STATING THE LEAK WAS OBSERVED. LEAKAGE WAS NOT OBSERVED PRIOR TO PATIENT THERAPY. THIS OCCURRED DURING PATIENT USE. 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 INFUSOR LV5, 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10E022

    Patients

    Seq Age Sex Outcome Treatment
    1