BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG SPIKE ADAPTER W/CHEMOLOCK

    MDR report key: 5815997 · Received July 22, 2016

    Report

    Report Number
    2025816-2016-00074
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    June 22, 2016
    Report Date
    August 16, 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# 3120611 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN SEPTEMBER OF 2015 CITING NO ANOMALIES. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF SUSPECT LOT# 3120611 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN SEPTEMBER OF 2015 CITING NO ANOMALIES. VISUAL RECEIPT ANALYSIS: 1.8ML BAG SPIKE ADAPTER W/CHEMOLOCK AND VENTED CAP, SUSPECT LOT# 3120611. ONE USED CAREFUSION PUMPSET. ONE USED SPINNING SPIROS LOT# UNKNOWN. THE PUMPSET WAS SPIKED INTO THE CL3534. THE SPIROS WAS NOT CONNECTED TO THE SET. THE SETUP WAS FLUSHED AND NO LEAKS WERE OBSERVED. THE REPORTED CRACK WAS NOT IDENTIFIED. FUNCTION TESTING: A USED CL3534 CHEMOLOCK BAG SPIKE ADAPTER WAS RETURNED CONNECTED TO A CAREFUSION PUMP SET. A USED STAND ALONE SPINNING SPIROS WAS ALSO RETURNED. THE SPIN FEATURES ON BOTH THE CHEMOLOCK AND SPINNING SPIROS CONNECTORS WERE ACTIVATED. A MICROSCOPIC EXAMINATION OF BOTH THE CL3534 CHEMOLOCK BAG SPIKE ADAPTER AND SPINNING SPIROS DID NOT REVEAL ANY CRACKING. THE CL3534 CHEMOLOCK BAG SPIKE ADAPTER CONNECTED TO THE CAREFUSION PUMP SET WAS PRESSURE LEAK TESTED IN THE ACTIVATED POSITION. THERE WAS NO LEAKAGE DETECTED AT ANY LOCATION ALONG THE FLUID PATH. THE STANDALONE SPINNING SPIROS WAS PRESSURE LEAK TESTED AND NO LEAKAGE WAS DETECTED IN EITHER THE ACTIVATED OR UNACTIVATED POSITIONS. FINAL ANALYSIS SUMMARY: THE COMPLAINTS OF BREAKAGE/LEAKAGE OF THE CL3534 CHEMOLOCK BAG SPIKE ADAPTER AND USED SPINNING SPIROS WERE UNABLE TO BE CONFIRMED OR REPLICATED. BOTH PRODUCT ASSEMBLIES MET PRESSURE LEAK EXPECTATIONS OUTLINED IN THE PRODUCT PERFORMANCE SPECIFICATION. THERE WAS NO VISIBLE CRACKING OR OTHER DAMAGE VISIBLE ON THE CL3534 CHEMOLOCK BAG SPIKE ADAPTER OR SPINNING SPIROS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING THREE CL3534, 5" 1.8ML BAG SPIKE ADAPTER W/CHEMOLOCK AND VENTED CAP, SUSPECT LOT# 3120611 (MFD. 09/2016). IV BAG AND TUBING LEFT IN MY OFFICE WITH A NOTE THAT STATED THE BAG SPIKE ADAPTER CRACKED AGAIN ON THE CLEAR TUBING LUER PIECE RIGHT BELOW THE BLUE CLICK ON ADAPTER PORTION OF THE ADD ON DEVICE. THERE WAS UNPROTECTED CHEMO EXPOSURE REPORTED BUT NO SERIOUS ADVERSE PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING THREE CL3534, 5" 1.8ML BAG SPIKE ADAPTER W/CHEMOLOCK AND VENTED CAP, SUSPECT LOT# 3120611 (MFD. 09/2016). IV BAG AND TUBING LEFT IN MY OFFICE WITH A NOTE THAT STATED THE BAG SPIKE ADAPTER CRACKED AGAIN ON THE CLEAR TUBING LUER PIECE RIGHT BELOW THE BLUE CLICK ON ADAPTER PORTION OF THE ADD ON DEVICE. THERE WAS UNPROTECTED CHEMO EXPOSURE REPORTED BUT NO SERIOUS ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468843 BAG SPIKE ADAPTER W/CHEMOLOCK BAG SPIKE ADAPTER W/CHEMOLOCK ONB ICU MEDICAL, INC. CL3534 3120611

    Patients

    Seq Age Sex Outcome Treatment
    1