BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IV MONITORING KIT W/SAFESET

    MDR report key: 5496160 · Received March 11, 2016

    Report

    Report Number
    2025816-2016-00009
    Event Type
    Malfunction
    Date Received
    March 11, 2016
    Date of Event
    December 31, 2015
    Report Date
    January 12, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 3093599 (MFG. 09/2015) SHOWED (B)(4) UNITS WERE MFG. TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: THE INVOLVED 42648-06 MONITORING KIT WAS NOT RETURNED FOR ANALYSIS AND CONFIRMATION. CAUSE OF THE REPORTED EVENT/PRODUCT ISSUE ARE UNKNOWN. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    MEDSUN # (B)(4) RECEIVED CONCERNING MULTIPLE COMPONENT ISSUES (WITHDRAWAL/BREAKAGE) WITH USE OF 42648-06 TRANSPAC IV MTG. KIT. THE MEDSUN REPORT DESCRIBES THE (B)(6) 2015 EVENT AS FOLLOWS "NURSE WAS PRIMING A NEW ART LINE TUBING. AFTER HOOKING IT UP TO THE PATIENT, SHE NOTICED THE WAVEFORM WAS DAMPENED SO SHE TRIED TO PULL BACK THE PLUNGER/RESERVOIR. COULD NOT GET ANY BLOOD RETURN SO REPOSITIONED THE PATIENT'S WRIST AND PULLED BACK THE PLUNGER AGAIN. THEN NOTICED A LOT OF AIR IN THE RESERVOIR BUT NOT IN THE TUBING. THE PLUNGER/RESERVOIR WAS BROKEN SO ONLY THE PLASTIC PART OF THE PLUNGER PULLED BACK, BUT THE SUCTION DEVICE STAYED IN PLACE AND WAS NOT PULLING BACK THE BLOOD. NO BLOOD EVER MADE IT TO THE RESERVOIR. THE PATIENT WAS NOT HARMED." ADDITIONAL EVENT INFORMATION AND DEVICE RETURN STATUS ALTHOUGH REQUESTED AS OF THIS DATE HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151416 TRANSPAC IV MONITORING KIT W/SAFESET TRANSPAC IV MONITORING KIT W/SAFESET DRS ICU MEDICAL, INC. 42648-06 3093599

    Patients

    Seq Age Sex Outcome Treatment
    1