BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMBI-SET NON-MACHINE SPEC 8MM NO DC

    MDR report key: 207396 · Received January 21, 1999

    Report

    Report Number
    8030665-1999-00021
    Event Type
    Injury
    Date Received
    January 21, 1999
    Date of Event
    December 9, 1998
    Report Date
    January 20, 1999
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REC'D NOTICE OF COMPLAINT CONCERNING ABOVE PRODUCT FROM CLINICAL INSERVICE SPECIALIST. REPORTS THAT FACILITY HAS HAD NUMEROUS COMPLAINTS CONCERNING THIS LINE. SPOKE WITH FACILITY NURSE MANAGER WHO ALSO REPORTS PUMP SEGMENT LEAKS (BLOOD LOSS REPORTED AS LESS THAN 20CC-NO PT INJURY), CLOTTED VENOUS LINES...NURSE MANAGER TO RETURN PHONE CALL ON 12/10 IN ORDER TO PROVIDE SAMPLE INFO AND MORE SPECIFIC CLINICAL INFO AS TWO EVENTS (INVOLVING CLOTTED VENOUS LINES PIR#9802047) INVOLVED BLOOD LOSS>100CC. MEDWATCHES FILED BASED ON BLOOD LOSS. ALSO STATES ARTERIAL LINE IS TOO SHORT, TRANSDUCERS NEED TO BE CHANGED 2-3X PER TREATMENT, VENOUS CHAMBER TOO NARROW. 12/10-NO INFO REC'D FROM FACILITY. MESSAGE LEFT FOR NURSE MANAGER TO RETURN CALL. 12/21-LEFT MESSAGE AT FACILITY FOR NURSE MANAGER TO RETURN CALL. 1/18-SPOKE WITH NURSE MANAGER. STATES STILL CONTINUING TO HAVE SOME PROBLEMS BUT DID NOT HAVE TIME TO ELABORATE. ASKED TO RETURN CALL AT "3PM." RETURNED CALL AT THIS TIME, NURSE MANAGER NOT AVAILABLE TO COME TO PHONE. 1/19-CALLED FACILITY AGAIN TO OBTAIN NECESSARY INFO, NURSE MANAGER REPORTS THAT SHE IS UNABLE TO PROVIDE THE REQUESTED INFO AT THIS TIME DUE TO OTHER FACILITY COMMITTMENTS. PIR/MEDWATCH CREATED 1/20/99 AS HAD BEEN WAITING FOR REQUESTED INFO FROM FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBI-SET NON-MACHINE SPEC 8MM NO DC BLOODLINE FOR HEMODIALYSIS FJK ERIKA DE REYNOSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other FRESENIUS DIALYSIS MACHINE.