BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IV TRIFURCATED MONITORING KIT

    MDR report key: 5932329 · Received September 7, 2016

    Report

    Report Number
    2025816-2016-00126
    Event Type
    Malfunction
    Date Received
    September 7, 2016
    Date of Event
    August 8, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3242551 SHOWED THAT 30 UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN (B)(6) 2016, CITING NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3242551 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MAY OF 2016, CITING NO ANOMALIES. DEVICES RECEIVED: 9/30/2016 - ON 8/15/2016 RECEIVED THE FOLLOWING: ONE OPENED UNUSED 46110-72, TRANSPAC IV TRIFURCATED MONITORING KIT, REPORTED LOT# 3242551. ONE USED 46110-72, TRANSPAC IV TRIFURCATED MONITORING KIT, SUSPECT LOT# 3242551 - PARTIAL DEVICE RETURNED, ONLY THE BD 10ML SYRINGE AND THE ATTACHED PRESSURE TUBING. THE PRESSURE TUBING WAS CONFIRMED TO HAVE BEEN PULLED OUT OF THE MALE LUER WHICH WAS ATTACHED TO THE 3-WAY STOPCOCK. A SOLVENT RING WAS OBSERVED ON THE TUBING. FUNCTIONAL TESTING: USED TUBING WAS VISUALLY EXAMINED. A SOLVENT RING WAS OBSERVED AROUND THE TUBING AND THE TUBING WAS OBSERVED TO BE BETWEEN 4 AND 5 MM FOR INSERTION DEPTH MEETING SPECIFICATION. THE NEW UNUSED UNIT WAS PULL TESTED AND WAS OBSERVED TO FAIL AT THE BOND WITH 13.81 LBF. A SOLVENT RING WAS OBSERVED ALL THE WAY AROUND. FINAL SUMMARY: THE REPORTED COMPLAINT OF TUBING DETACHED WAS CONFIRMED THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED AS A SOLVENT RING WAS OBSERVED ALL THE WAY AROUND THE TUBING AND AN ADEQUATE INSERTION DEPTH OF THE TUBING INTO THE LUER POCKET WAS ALSO OBSERVED. THE NEW UNUSED UNIT WAS PULL TESTED AND WAS OBSERVED TO HAVE A PEAK FORCE OF 13.89 LBF BEFORE FAILURE. THIS EXCEEDS THE SPECIFICATION OF 6 LBF. THE USED TUBING APPEARS TO HAVE BEEN A GOOD BOND.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING TWO 46110-72, TRANSPAC IV TRIFURCATED MONITORING KIT, SUSPECT LOT#S 3242551 (MFD B)(6). I HAVE A PRODUCT FAILURE FOR THIS ITEM. ART LINE PORTION OF THE SET WAS BEING USED TO DRAW BLOOD FROM POINT. SAMPLING TUBING DETACHED FROM STOPCOCK WHERE IT WAS BONDED. SECOND INCIDENT, TUBING WAS KEPT THAT FELL OFF. HOWEVER, THE REST OF THE SET WAS DISCARDED BECAUSE IT CONTAINED BLOOD. FIRST INCIDENT, NO PRODUCT WAS KEPT. I WILL BE SENDING THE TUBING THAT FELL OFF AND AN EXAMPLE OF THE SET AS A WHOLE. I DID MARK THE SPOT WHERE IT CAME OFF IN THE TWO PREVIOUS INCIDENTS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING TWO 46110-72, TRANSPAC IV TRIFURCATED MONITORING KIT, SUSPECT LOT#S 3242551 (MFD. 05/16). I HAVE A PRODUCT FAILURE FOR THIS ITEM. ART LINE PORTION OF THE SET WAS BEING USED TO DRAW BLOOD FROM POINT. SAMPLING TUBING DETACHED FROM STOPCOCK WHERE IT WAS BONDED. SECOND INCIDENT, TUBING WAS KEPT THAT FELL OFF. HOWEVER, THE REST OF THE SET WAS DISCARDED BECAUSE IT CONTAINED BLOOD. FIRST INCIDENT, NO PRODUCT WAS KEPT. I WILL BE SENDING THE TUBING THAT FELL OFF AND AN EXAMPLE OF THE SET AS A WHOLE. I DID MARK THE SPOT WHERE IT CAME OFF IN THE TWO PREVIOUS INCIDENTS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583996 TRANSPAC IV TRIFURCATED MONITORING KIT TRANSPAC MONITORING KIT DRS ICU MEDICAL, INC. 46110-72 3242551 (SUSPECT)

    Patients

    Seq Age Sex Outcome Treatment
    1