BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMBISET

    MDR report key: 2973991 · Received July 16, 2007

    Report

    Report Number
    8030665-2007-00054
    Event Type
    Injury
    Date Received
    July 16, 2007
    Date of Event
    June 7, 2007
    Report Date
    July 16, 2007
    Manufacturer
    REYNOSA MFG
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: (B)(4) 2007. IT IS THE BELIEF OF FMC NA THAT THIS EVENT WAS USER ERROR AND NOT THE FAULT OF THE HEMODIALYSIS MACHINE OR THE BLOODLINES BECAUSE OF THE VERBAL STATEMENT BELOW. THE CLINICAL MGR OF THIS UNIT HAS REPORTEDLY VERBALLY, THAT THIS EVENT WAS CAUSED BY USER ERROR AND WAS NOT MACHINE OR BLOODLINE RELATED. ADDITIONAL INFO FROM USER FACILITY REPORT: (B)(4).

    Description of Event or Problem · 1

    AN ELECTRONIC REPORT WAS RECEIVED FROM A HEMODIALYSIS USER FACILITY. IT WAS LEARNED THAT INITIALLY THIS PT STARTED THEIR DIALYSIS TREATMENT WITH THE BLOODLINE CONNECTORS CONNECTED TO THE PERM CATH IN THE CORRECT POSITION. IT WAS REPORTED THAT THE LINES WERE THEN REVERSED SOMETIME DURING THE TREATMENT. IT WAS FOUND AT THE TIME OF THE EVENT, THE ARTERIAL CONNECTOR WAS CONNECTED TO THE VENOUS PORTION OF THE PERM CATH AND THE VENOUS BLOODLINE CONNECTOR WAS ATTACHED TO THE ARTERIAL PORTION OF THE PERM CATH. IT WAS ALSO LEARNED THAT THERE WAS NOT A HEMO CLIP IN PLACE TO SECURE THE CONNECTIONS AT THE TIME OF THE DEVICE. THE PT DID RECEIVE 2 UNITS OF PRBC AS A RESULT OF THIS EVENT. THE PT REMAINED INPATIENT FOR 3 DAYS. THE PT HAS RECOVERED FROM THIS EVENT. THE PT WAS DISCHARGED TO HOME. ADDITIONAL INFO FROM USER FACILITY REPORT: PT HYPOTENSIVE AT 2 HRS - 25 MINUTES INTO TREATMENT. PT UNRESPONSIVE. MACHINE ALARM "AIR IN BLOOD". ACCESS EXPOSED; VENOUS BLOOD-LINE DISCONNECTED FROM ARTERIAL PERM CATH LIMB. AIR NOTED IN SYSTEM. ALSO NOTED 300-500 ML BLOOD ON FLOOR UNDER PT'S CHAIR. BLOOD NOT RETURNED TO PT. O2 ON PER MASK. PT BAGGED X2 BREATHS WITH GOOD RESPONSE. 911 CALLED. PT GIVEN 800 MLS N/S. TRANSFERRED TO (B)(6). PT RESPONSIVE AND ALERT ON LEAVING UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBISET HEMODIALYSIS BLOOD TUBING SET FJK REYNOSA MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention FMC NA HEMODIALYSIS MACHINE 2008K