BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2873153 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07328
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE UNIT IN ITS ORIGINAL UNOPENED OVERPOUCH FOR EVALUATION. VISUAL EXAMINATION OF THE UNIT CONFIRMED THAT THE FILL PORT CAP WAS MISSING FROM THE FILL PORT. FURTHER EXAMINATION OF THE FILL PORT AND CAP SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. THE ROOT CAUSE WAS OPERATOR ERROR DURING THE MANUAL FILL PORT CAP ASSEMBLY PROCESS. AS A RESULT OF THIS INCIDENT, AWARENESS TRAINING FOR ALL APPLICABLE MANUFACTURING OPERATORS WAS CONDUCTED IN (B)(4) 2012. 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 THAT AN INFUSOR HAD A MISSING FILLPORT CAP FOUND BEFORE USE. THIS POTENTIALLY CAUSED A BREACH IN THE STERILE FLUID PATHWAY OF THE DEVICE. 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 AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11J029

    Patients

    Seq Age Sex Outcome Treatment
    1