BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2882691 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07906
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. 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. THIS PRODUCT IS NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. A FUNCTIONAL LEAK TEST WAS PERFORMED ON THE PCM. AT THE NORMAL OPERATION SPECIFICATION OF 25 PSI, NO SIGNS OF LEAKAGE WERE OBSERVED ON ANY PART OF THE DEVICE. WHEN THE PRESSURE WAS INCREASED OUT OF OPERATIONAL SPECIFICATION RANGE TO 29 PSI, LEAK WAS NOTED INSIDE THE HOUSING. THEREFORE, THE REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED UNDER NORMAL OPERATIONAL SPECIFICATION OF 25 PSI. 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 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF A PATIENT CONTROL MODULE (PCM) THAT LEAKED AFTER FILLING. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. 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, PCA MEA BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1