BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR,LV 2 ML/H 12 PACK

    MDR report key: 2073545 · Received May 2, 2011

    Report

    Report Number
    6000001-2011-03340
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED ONE DEVICE FOR EVALUATION. LEAK CONDITION NOT CONFIRMED. THE BLADDER WAS SUBSEQUENTLY FILLED WITH DEXTROSE SOLUTION TO ITS MAXIMUM VOLUME. DURING AND AFTER FILL, NO EVIDENCE OF LEAK WAS NOTED AT THE FILLPORT. NO SIGNS OF DEFECT WERE OBSERVED FROM THE DEVICE UPON SAMPLE RECEIPT AND DURING TESTING. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF ONE (1) CE INFUSOR, LV 2 ML/H WHICH REPORTEDLY LEAKED AT THE FILLING PORT DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS EVENT, AS IT OCCURRED PRIOR TO PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR,LV 2 ML/H 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 08K072

    Patients

    Seq Age Sex Outcome Treatment
    1