BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS

    MDR report key: 6356049 · Received February 24, 2017

    Report

    Report Number
    2025816-2017-00039
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    July 27, 2016
    Report Date
    February 23, 2017
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT 3202211 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MARCH 2017, CITING NO EXCEPTION DOCUMENTS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE CH3033, 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS® W/RED CAP, VENTED CAP; LOT# 3202211 (MFD. 03/2016). REPORT STATES: THE CHEMOTHERAPY ADMINISTRATION SYSTEM HAS BEEN PERFORATED DURING THE INSERTION INTO THE PERFUSER. THE CLAMP WAS MOVED UPWARDS AS WRITTEN IN THE INSTRUCTIONS WHICH HAS CRUSHED THE TUBE. THIS WOULD HAVE CAUSED THE PERFORATION. THERE WAS A MINIMAL LOSS OF CHEMOTHERAPY AND RISK FOR THE PATIENT AND THE MEDICAL STAFF. UNPROTECTED CHEMO EXPOSURE REPORTED. NO ADVERSE PATIENT/CLINICIAN CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138165 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS FPA ICU MEDICAL, INC. CH3033 3202211

    Patients

    Seq Age Sex Outcome Treatment
    1