BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC MONITORING KIT

    MDR report key: 5936091 · Received September 8, 2016

    Report

    Report Number
    2025816-2016-00125
    Event Type
    Malfunction
    Date Received
    September 8, 2016
    Date of Event
    August 11, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT LOT REVIEW: A REVIEW OF LOT# 3242465 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MAY 2016 CITING NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    SUSPECT LOT REVIEW:A REVIEW OF LOT# 3242465 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MAY 2016 CITING NO ANOMALIES. DEVICE RECEIPT: 8/17/2016 - RECEIVED ONE USED 42582-05, TRANSPAC IV DISPOSABLE TRANSDUCER LOT# UNKNOWN. THE TRANSDUCER WAS FLUSHED. FUNCTIONAL TESTING: THE TRANSPAC PASSED TRANSPAC FUNCTIONAL TESTING AND MEET SPECIFICATION. NO DEFECT WAS FOUND. FINAL ANALYSIS: THE REPORTED COMPLAINT OF TRANSDUCER READINGS FLUCTUATED COULD NOT BE CONFIRMED. TRANSPAC MET SPECIFICATION.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING THREE 46085-47, MONITORING KIT. REPORT STATES, ONE OR MORE OF THE TRANSDUCERS ON THESE TRIFURCATED CUSTOM KITS STOPPED PRODUCING A WAVEFORM AND PRESSURE READING. AIR WAS DISCOVERED ENTERING THE SYSTEM THROUGH THE TRANSPAC HOUSING. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING THREE 46085-47, MONITORING KIT. REPORT STATES, ONE OR MORE OF THE TRANSDUCERS ON THESE TRIFURCATED CUSTOM KITS STOPPED PRODUCING A WAVEFORM AND PRESSURE READING. AIR WAS DISCOVERED ENTERING THE SYSTEM THROUGH THE TRANSPAC HOUSING. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588839 TRANSPAC MONITORING KIT TRANSPAC DRS ICU MEDICAL, INC. 46085-47 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1