BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPAC IV MONITORING KIT

    MDR report key: 3151878 · Received May 20, 2013

    Report

    Report Number
    2025816-2013-00050
    Event Type
    Other
    Date Received
    May 20, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION: A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT NUMBER 2512809 (MFG DATE: 06/01/2012) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. CONCLUSION: THE INVOLVED (B)(4) MONITORING KIT WAS NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE OF THE PROBLEM IS UNK. THIS COMPLAINT AND ASSOCIATED INFO HAVE BEEN ENTERED IN THE MANUFACTURER'S DATABASE FOR ANALYSIS AND TRENDING. MANUFACTURING LOT RECORDS WERE REVIEWED; COMPLAINT TRENDING ANALYSIS PERFORMED.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED CONCERNING READING ISSUES WITH USE OF ONE (B)(4) TRANSPAC IV MONITORING. KIT. IT WAS REPORTED THAT THE "ARTERIAL INTRAVENOUS (IV) LINE MONITORING TRANSDUCER WAS NOT WORKING. WE COULD NOT GET A BLOOD PRESSURE AND ONCE THE TUBING WAS CHANGED, IT WAS WORKING PROPERLY". THERE WERE NO REPORTED PATIENT INJURIES AND OR ADVERSE CONSEQUENCES. ALTHOUGH REQUESTED, THE INVOLVED (B)(4) MONITORING KIT AND/OR SAME LOT SAMPLE WERE NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AND CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221554 TRANSPAC IV MONITORING KIT TRANSPAC IV MONITORING KIT DRS ICU MEDICAL, INC. 42607-05 2512809

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR