BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR

    MDR report key: 6540227 · Received May 3, 2017

    Report

    Report Number
    2025816-2017-00112
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    February 15, 2016
    Report Date
    May 3, 2017
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF THE MFG. LOT DATABASE FOR SUSPECT LOT# 3330120 (MFG. DATE 09/2016) SHOWS (B)(4) UNITS WERE MFGD., TESTED, INSPECTED, AND RELEASED, CITING NO EXCEPTION DOCUMENTS. VISUAL INSPECTION: RECEIVED ONE USED 42646-06, TRANSPAC IV MONITORING KIT. THE RESERVOIR AND TWO SSII PORTS RETURNED AND 12 INCH TUBING. THE MALE LUER CONNECTOR ON THE 3 INCH TUBING WAS SEPARATED AT THE BOND. THERE IS A SOLVENT RING ON THE TUBING. THE PRESSURE TUBING OF THE 3" DISTAL SECTION AND THE DISTAL MALE LUER WAS VISUALLY OBSERVED UNDER MAGNIFICATION. THE PRESSURE TUBING AND THE DISTAL MALE LUER WERE OBSERVED TO HAVE A FULL AND COMPLETE SOLVENT RING. FINAL ANALYSIS SUMMARY: THE REPORTED COMPLIANT OF BROKEN WAS VISUALLY CONFIRMED. THE ROOT CAUSE OF THE FAILURE IS BELIEVED TO HAVE BEEN CAUSED FROM UNINTENDED FORCE. THE TUBING AND THE LUER BOTH EXHIBITED PROMINENT SOLVENT RINGS. THESE RINGS INDICATE THAT THE BOND WAS ADEQUATE. ICU MEDICAL WILL CONTINUE TO MONITOR AND TREND THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT REC'D REGARDING ONE (1) 42646-06, TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT); LOT# UNKNOWN. THE REPORT STATES, THE PATIENT NOTIFIED THE NURSE THAT THERE WAS A PROBLEM. UPON INSPECTION, THE NURSE REALIZED THAT THE PLASTIC HAD BROKEN AND WAS NOT AT AN CONNECTION POINT. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322029 TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR DRS ICU MEDICAL INC. 42646-06 3330120

    Patients

    Seq Age Sex Outcome Treatment
    1