BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2260273 · Received September 22, 2011

    Report

    Report Number
    6000001-2011-26322
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    July 20, 2011
    Report Date
    September 5, 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). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, THIS PRODUCT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK AT THE FILL PORT WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. TO VERIFY THE REPORTED DEFECT, THE UNIT WAS MANUALLY FILLED WITH WATER TO ITS MAXIMUM VOLUME. DURING AND AFTER FILL, NO EVIDENCE OF LEAKAGE WAS NOTED AT THE FILL PORT. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR LEAKED AT THE FILL PORT DURING FILLING. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09J069

    Patients

    Seq Age Sex Outcome Treatment
    1