BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL KIT

    MDR report key: 5854907 · Received August 8, 2016

    Report

    Report Number
    2025816-2016-00085
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    July 17, 2016
    Report Date
    September 8, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF SUSPECT LOT# 3226622 SHOWED THAT (B)(4). STARTED INVESTIGATION AND FOLLOW UP TO BE FILED.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3226622 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MARCH OF 2016 CITING NO ANOMALIES. A REVIEW OF LOT# 3202076 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MARCH OF 2016 CITING NO ANOMALIES. THE 21 UNUSED UNITS FROM OTHER LOTS WERE SENT FOR INVESTIGATION AND A THIRD USED UNIT, AS EXPLAINED IN THE NOTE BELOW. NOTE: THERE WERE THREE UNITS (NOT TWO AS ORIGINALLY WRITTEN IN THE INITIAL COMPLAINT - MDR) ALL USED ON THE SAME PATIENT. THE OTHER USED UNIT WAS FROM LOT# 3265497 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN JUNE 2016. FUNCTIONAL TESTING: THE USED UNIT FROM LOT# 3202076 AND LOT# 3226622 PASSED BOTH PRESSURE AND VACUUM TESTING AND DID NOT CONFIRM THE COMPLAINT. THE USED UNIT FROM LOT# 3265497 PASSED PRESSURE BUT FAILED VACUUM TESTING. THE 21 UNUSED UNITS HAD MIXED RESULTS. ANALYSIS SUMMARY: THE REPORTED COMPLAINT OF LEAK FROM THE TRANSDUCER WAS CONFIRMED ON THE ONE USED UNIT. ONE OF THE THREE USED UNITS WAS OBSERVED TO LEAK WHICH WAS FROM LOT# 3265497. THE OTHER 21 UNITS FROM VARIOUS LOTS HAD MIXED RESULTS. THE ROOT CAUSE OF THE FAILURE WAS DETERMINED TO BE A MANUFACTURING ERROR DEALING WITH THE TRANSPAC HIGH CHIP. ICU THROUGH CONTINUOUS IMPROVEMENT IS REVIEWING AND CHALLENGING THE APPLICABLE DESIGN, MATERIALS AND INVOLVED MANUFACTURING AND EQUIPMENT PROCESSES. ICU WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING TWO 46068-65, NEONATAL KIT WITH 30ML, FLUSH DEVICE FOR (B)(6) HOSPITAL, SUSPECT LOT NUMBERS 3202076 (MFD. 03/2016) AND 3226622 (MFD. 03/2016). " THE TRANSDUCER WAS CONNECTED TO A UAC ON A NICU BABY - AFTER CONNECTING THE LINE, BLOOD STARTED TO LEAK FROM THE TRANSDUCER - ACCORDING TO THE ACCOUNT. LEAKING WAS STATED AS OCCURRING BEHIND THE TRANSDUCER CASING. DELAY IN CRITICAL THERAPY DUE TO UNSCHEDULED CHANGE OUT OF DEVICE WAS REPORTED BUT NO SERIOUS ADVERSE PATIENT CONSEQUENCES WERE REPORTED. PATIENT BASELINE REMAINED UNCHANGED, STABLE AND POST STATUS IS GOOD.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING TWO 46068-65, NEONATAL KIT WITH 30ML, FLUSH DEVICE FOR (B)(6) HOSPITAL, SUSPECT LOT NUMBERS 3202076 (MFD. 03/2016) AND 3226622 (MFD. 03/2016). " THE TRANSDUCER WAS CONNECTED TO A UAC ON A NICU BABY - AFTER CONNECTING THE LINE, BLOOD STARTED TO LEAK FROM THE TRANSDUCER - ACCORDING TO THE ACCOUNT. LEAKING WAS STATED AS OCCURRING BEHIND THE TRANSDUCER CASING. DELAY IN CRITICAL THERAPY DUE TO UNSCHEDULED CHANGE OUT OF DEVICE WAS REPORTED BUT NO SERIOUS ADVERSE PATIENT CONSEQUENCES WERE REPORTED. PATIENT BASELINE REMAINED UNCHANGED, STABLE AND POST STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507594 NEONATAL KIT NEONATAL KIT DRS ICU MEDICAL, INC. 46068-65 3202076 AND 3226622

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA