BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B9220, 84" BI-FUSE BLOOD SET

    MDR report key: 588167 · Received June 30, 2004

    Report

    Report Number
    2025816-2004-00001
    Event Type
    Malfunction
    Date Received
    June 30, 2004
    Date of Event
    February 24, 2004
    Report Date
    June 28, 2004
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA RECEIPT OF FACILITY VOLUNTARY MW 1031575, THAT THE FILTER CHAMBER ON ONE (1) B9220 Y TYPE BLOOD SET CRACKED AND LEAKED. THE REPORT STATES THAT THE HEALTH PROFESSIONAL "SQUEEZED THE CHAMBER A COUPLE OF TIMES SO THE BLOOD WOULD FILL ABOVE THE WHITE PLASTIC PIECE, THEN IT CRACKED." LIMITED INFO WAS PROVIDED AND OR KNOWN REGARDING THE INCIDENT. IT IS UNK HOW LONG THE B9220 DEVICE WAS IN USE, WHAT CONCOMITANT PRODUCTS, DEVICES AND OR ATTACHMENTS WERE INVOLVED. ONE (1) B9220 DEVICE WAS RETURNED TO ICU MEDICAL, INC. FOR DECONTAMINATION, TESTING AND ANALYSIS. VISUAL INSPECTION RECORDED THAT THE PLASTIC HOUSING FOR THE FILTER CHAMBER WAS DAMAGED AS EVIDENCED BY A HOLE IN THE PLASTIC. THERE WERE NO VISIBLE CRACKS. THE PRESENCE OF THE HOLE WOULD ALLOW TO LEAK THROUGH. THE INVOLVED MFG PROCESSES INCLUDING THE ASSEMBLY WORK/SET UP AREAS WERE EVALUATED. THE INVESTIGATION RECORDED NO MECHANICAL/SHARP EQUIPMENT IS PRESENT AT THE WORKSTATION WHERE THE DEVICE IS MANUALLY ASSEMBLED. ALTHOUGH THE EXACT CAUSE(S) OF THE FILTER CHAMBER DAMAGE ARE UNK THE MANUFACTURERS' INVESTIGATION CONCLUDED IT WAS NOT ATTRIBUTABLE TO THE MFG PROCESSES AND MOST LIKELY OCCURRED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B9220, 84" BI-FUSE BLOOD SET IV SET FPA ICU MEDICAL, INC. B9220 192700

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO