BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC MONITORING KIT

    MDR report key: 5936046 · Received September 8, 2016

    Report

    Report Number
    2025816-2016-00122
    Event Type
    Malfunction
    Date Received
    September 8, 2016
    Date of Event
    August 10, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Removal / Correction Number
    2025816-08/18/2016-004-R
    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: (B)(4).

    Additional Manufacturer Narrative · 1

    SUSPECT LOT REVIEW: A REVIEW OF SUSPECT LOT# 3265536 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN JUNE 2016 CITING NO ANOMALIES. A REVIEW OF SUSPECT LOT# 3242465 SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MAY 2016 CITING NO ANOMALIES. DEVICE RETURN: 8/18/2016 - RECEIVED ONE USED MONITORING KIT W/03ML FLUSH DEVICE FOR (B)(6) HOSP. CTR. LOT# 3265536. THE PA DISTAL TRANSDUCER WAS NOT RETURNED. ON 8/19/2016 - 8/19/2016 - ADDITIONAL DEVICES WERE RECEIVED. ONE NEW 46085-47 MONITORING KIT W/03ML FLUSH DEVICE FOR (B)(6) HOSP. CTR. LOT# 3265536 THREE USED MONITORING KIT W/03ML FLUSH DEVICE FOR (B)(6) HOSP. CTR. UNKNOWN LOT BUT REPORTED AS LOT# 3265536 A NOTE WAS RECEIVED FROM THE PSR STATING THE LOT NUMBERS OF THE USED DEVICES COULD NOT BE CONFIRMED AND THAT AT LEAST ONE TRANSDUCER ON EACH KIT WAS NOT WORKING. THE DEVICES ARRIVED WET IN PLASTIC BAGS. ENGINEERING TESTING AND ANALYSIS TO THE APPLICABLE PRODUCT AND PERFORMANCE SPECIFICATIONS WAS PERFORMED. INITIAL LEAK AND RESTRICTION TESTING RECORDED NO LEAKAGES. ADDITIONAL VACUUM TESTING TO SIMULATE THE EFFECTS OF BLOOD DRAW RECORDED LEAKAGES SEEN INSIDE THE TRANSPAC WITH AIR BEING PULLED INTO THE FLUID PATH ON THE FIVE RETURNED COMPLAINT SAMPLES (TRANSPAC ASSY. SECTIONS) ADDITIONAL DETAILED INVESTIGATION EFFORTS ARE IN PROGRESS. TO DATE THE INVESTIGATIONS IDENTIFIED THE CAUSE WAS POTENTIALLY ATTRIBUTABLE TO THE TRANSDUCERS NOT FULLY SEATED INTO THE MATING COMPONENT. DURING SUBSEQUENT ULTRASONIC WELDING PROCESSES THE TRANSDUCER COMPONENTS MIGHT POTENTIALLY BE COMPROMISED RESULTING IN A VACUUM LEAK. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN QUALIFIED AND IMPLEMENTED. ON AUGUST 18TH, 2016 ICU MEDICAL INC. INITIATED A VOLUNTARY US FDA RECALL OF THE AFFECTED DEVICES. IT WAS BROADENED ON SEPTEMBER 27, 2016.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING THREE 46085-47, MONITORING KIT. REPORT STATES, THE TRANSDUCERS ON THIS CUSTOM TRIFURCATED KIT WOULD CONTINUOUSLY DROP THE WAVEFORM/PRESSURE READING. ALL PROPER TROUBLESHOOTING STEPS WERE PERFORMED (CHANGING PRESSURE CABLES, SQUARE WAVE TEST, RE-ZEROING, TESTING PHILIPS PRESSURE MODULES). DURING TROUBLESHOOTING THE CLINICIANS DISCOVERED THAT AIR WAS ENTERING THE SYSTEM THROUGH THE TRANSPAC IV HOUSING. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING THREE 46085-47, MONITORING KIT. REPORT STATES, THE TRANSDUCERS ON THIS CUSTOM TRIFURCATED KIT WOULD CONTINUOUSLY DROP THE WAVEFORM/PRESSURE READING. ALL PROPER TROUBLESHOOTING STEPS WERE PERFORMED (CHANGING PRESSURE CABLES, SQUARE WAVE TEST, RE-ZEROING, TESTING PHILIPS PRESSURE MODULES). DURING TROUBLESHOOTING THE CLINICIANS DISCOVERED THAT AIR WAS ENTERING THE SYSTEM THROUGH THE TRANSPAC IV HOUSING. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588230 TRANSPAC MONITORING KIT TRANSPAC DRS ICU MEDICAL, INC. 46085-47 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1