BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4102740 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32313
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS UNKNOWN LOT COULD HAVE BEEN PRODUCED AT EITHER THE (B)(4) MANUFACTURING SITE. THE BAXTER HEALTHCARE - (B)(4). THE BAXTER HEALTHCARE - (B)(4) ADDRESS WAS PROVIDED IN THE INITIAL MDR. EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE FOUND NO SEPARATIONS; HOWEVER, WHILE THE SAMPLE WAS BEING DISINFECTED, THE MALE LUER SEPARATED FROM THE TUBING. MICROSCOPIC EXAMINATION OF THE TUBING END FOUND THAT THERE WAS NO VISIBLE SOLVENT PLOW RIDGE. THE REMAINING SOLVENT BONDS WERE THEN PULL TESTED WITH NO FAILURES NOTED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE SEPARATION WAS UNABLE TO BE DETERMINED. IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK BLOOD/SOLUTION SET DISCONNECTED FROM THE Y-SITE OF THE SET AND WAS LEAKING. THE REPORTER STATED THAT THIS OCCURRED DURING INFUSION OF BLOOD TO THE PATIENT AT A RATE OF 125CC/HOUR WITH AN UNKNOWN PUMP. IT WAS REPORTED THAT THE LEAKING BLOOD CAME IN CONTACT WITH THE PATIENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583879 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INFUSION PUMP