BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS

    MDR report key: 50517 · Received July 2, 1996

    Report

    Report Number
    50517
    Event Type
    Injury
    Date Received
    July 2, 1996
    Date of Event
    March 7, 1996
    Report Date
    March 18, 1996
    Manufacturer
    FRESENIUS USA
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIALYSIS TRETMENT WAS INITIATED WITHOUT DIFFICULTY NEAR (R) SUBCLAVIAN CATHETER AT 4:05 PM. APPROX TWO HRS INTO TREATMENT NURSE OBSERVED THAT PT DID NOT LOOK WELL. BP 80/90 (PRIOR BP 152/72). THE NURSE PUT THE PT'S CHAIR BACK TO ELEVATE HER FEET AND WENT TO THE MACHINE TO ADMINISTER SALINE. SHE NOTED A LARGE AMOUNT OF BLOOD ON THE FLOOR. THE ARTERIAL LINE WAS NOTED TO BE KINKED IN THE BLOOD PUMP AND BLOOD WAS LEAKING ON THE FLOOR. PT'S BLOOD WAS RETURNED, TREATMENT WAS TERMINATED AND ADD'L SALINE WAS ADMINISTERED. THE PT REFUSED TO GO TO THE ER FOR FURTHER EVALUATION. SHE WAS DISCHARGED FROM THE UNIT BP 130/70 SITTING 120/60 STANDING. THE NEXT MORNING FOLLOWING THE EVENT THE BLOOD PUMP ON THE MACHINE USED DURING THE ABOVE INCIDENT WAS MAKING A CLANKING NOISE WHEN THE TECH TURNED ON THE PUMP TO PRIME THE ARTERIAL BLOOD LINE. A SPRING AND OTHER PARTS OF THE BLOOD PUMP FELL TO THE FLOOR WHEN THE ARTERIAL LINE WAS TAKEN OUT TO INVESTIGATE THE NOISE. A NEW BLOOD PUMP WAS PLACED ON THE MACHINE AFTER FURTHER EVALUATION. IT WAS FELT THAT IMPROPER FUNCTIONING OF THE BLOOD PUMP CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS HEMODIALYSIS MACHINE FII FRESENIUS USA 2008 E *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| O| R NMC CONCENTRATE 8801| NMC BLOODLINES 7221/7303, FRESENIUS +80 B DIALYZER