BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    42" ADMIN SET, DROP IN-LINE CHAMBER, W/CHEMOLOCK

    MDR report key: 5815999 · Received July 22, 2016

    Report

    Report Number
    2025816-2016-00075
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    June 23, 2016
    Report Date
    August 26, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    ONB
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF SUSPECT LOT# 3249998 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MAY OF 2016 CITING NO ANOMALIES. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF SUSPECT LOT# 3249998 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN MAY OF 2016 CITING NO ANOMALIES. COMPLAINT RECEIPT: 8/8/2016 - RECEIVED ONE 7/26/2016 - ONE CL3361, 42" ADMIN SET, DROP IN-LINE CHAMBER, W/CHEMOLOCK, SUSPECT LOT# 3249998. ONE USED CAREFUSION PUMPSET. ONE USED SPINNING SPIROS LOT# UNKNOWN. FUNCTIONAL TESTING: A SINGLE USED CL3361 ADMIN SET WITH CHEMOLOCK AND A CAREFUSION PUMP SET WITH SPINNING SPIROS AT THE DISTAL END WERE RETURNED FOR INVESTIGATION. THE CAREFUSION SET WITH THE SPINNING SPIROS WAS PRESSURE LEAK TESTED I. NO LEAKAGE WAS OBSERVED AT ANY LOCATION ALONG THE FLUID PATH. THE USED CL3361 ADMIN SET WITH CHEMOLOCK WAS PRESSURE LEAK TESTED I. THERE WAS LEAKAGE DETECTED COMING FROM THE SPIN MECHANISM OF THE CHEMOLOCK CONNECTOR. THE CHEMOLOCK CONNECTOR WAS DISASSEMBLED WITH THE FOLLOWING OBSERVATIONS: THE FML SEAL WAS DISTORTED/MISSHAPEN. THIS WAS LIKELY THE CAUSE OF THE LEAKAGE. ANALYSIS SUMMARY: THE COMPLAINT OF USED CL3361 ADMIN SET WITH CHEMOLOCK LEAKAGE WAS CONFIRMED. THE LEAKAGE WAS IN THE LOCATION OF THE CHEMOLOCK SPIN FEATURE. WHEN DISASSEMBLED THE FML SEAL WAS DISTORTED AND MISSHAPEN RESULTING IN LEAKAGE. IT IS NOT KNOWN WHEN OR WHERE THE FML SEAL WAS DISTORTED/MISSHAPEN. THIS IS AN ISOLATED EVENT AND ICU MEDICAL HAS NOTIFIED QA AND MANUFACTURING FOR THEIR HEIGHTENED AWARENESS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE CL3361, 42" ADMIN SET, DROP IN-LINE CHAMBER, WITH CHEMOLOCK, SUSPECT LOT# 3249998 (MFG. 05/2016). TOLD THAT CHEMOTHERAPY TUBING WAS PRIMED AND HUNG. APPROXIMATELY 30 MINUTES LATER THEY NOTICED IT LEAKING AT THE CLEAR TUBING JUNCTION OF THE SECONDARY TUBING RIGHT BELOW THE BLUE CLICK DEVICE THAT SNAPS TO THE BAG SPIKE. THERE WAS UNPROTECTED CHEMO EXPOSURE REPORTED BUT CLEANED PER HOSPITAL PROTOCOL. NO SERIOUS ADVERSE CLINICIAN/PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE CL3361, 42" ADMIN SET, DROP IN-LINE CHAMBER, W/CHEMOLOCK, SUSPECT LOT# 3249998 (MFD. 05/2016). TOLD THAT CHEMOTHERAPY TUBING WAS PRIMED AND HUNG. APPROXIMATELY 30 MINUTES LATER THEY NOTICED IT LEAKING AT THE CLEAR TUBING JUNCTION OF THE SECONDARY TUBING RIGHT BELOW THE BLUE CLICK DEVICE THAT SNAPS TO THE BAG SPIKE. THERE WAS UNPROTECTED CHEMO EXPOSURE REPORTED BUT CLEANED PER HOSPITAL PROTOCOL. NO SERIOUS ADVERSE CLINICIAN/PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470307 42" ADMIN SET, DROP IN-LINE CHAMBER, W/CHEMOLOCK 42" ADMIN SET, DROP IN-LINE CHAMBER, W/CHEMOLOCK ONB ICU MEDICAL, INC. CL3361 3249998

    Patients

    Seq Age Sex Outcome Treatment
    1