BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2920396 · Received January 17, 2013

    Report

    Report Number
    1416980-2013-01272
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME 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 PCM WAS RETURNED WITH THE UNIT. VISUAL EXAMINATION CONFIRMED THE REPORTED CONDITION OF A LEAK. THE LEAK WAS CAUSED BY SEPARATED TUBING AT THE JUNCTION BETWEEN THE FEMALE LUER. THE ROOT CAUSE OF THE SEPARATED TUBING WAS DETERMINED TO BE INSUFFICIENT SOLVENT ON THE TUBING. AS A RESULT OF THIS INCIDENT, THE COMPLAINT SAMPLE WAS USED TO BRING AWARENESS TO ALL APPLICABLE MANUFACTURING OPERATORS IN (B)(6) 2013. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. 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 FROM THE HOSPITAL THAT AN INFUSOR HAD A SEPARATED LUER CAP DURING PATIENT USE. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THIS POTENTIALLY CAUSED A BREACH IN THE STERILE FLUID PATHWAY OF THE DEVICE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25334 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12A036

    Patients

    Seq Age Sex Outcome Treatment
    1