BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE EXT SET

    MDR report key: 5771962 · Received July 6, 2016

    Report

    Report Number
    2025816-2016-00060
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 9, 2016
    Report Date
    July 29, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K081361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A TWO (2) YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST/SIMILAR PROBLEM DID RECORD ADDITIONAL REPORTS AND INVESTIGATIONS. A REVIEW OF THOSE INVESTIGATIONS WHERE DEVICES WERE RETURNED RECORDED MIXED RESULTS.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A TWO (2) YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST/SIMILAR PROBLEM DID RECORD ADDITIONAL REPORTS AND INVESTIGATIONS. A REVIEW OF THOSE INVESTIGATIONS WHERE DEVICES WERE RETURNED RECORDED MIXED RESULTS. VISULA ANALYSIS: RECEIVED ON 6/13/2016 - SIX - ONE USED FIVE NEW ONE CH3353, 60" SMALLBORE EXT SET W/MICROCLAVE CLEAR, SPIROS AND CLAMP, LOT# 3232820. ONE USED BD 10ML SYRINGE, ONE USED CH2000S SPIROS. FUNCTIONAL TESTING: EACH WAS PRESSURE LEAK TESTED. THE USED CH3353 EXTENSION SET DID LEAK IN THE ACTIVATED POSITION AT THE HALF SEAL. THE FIVE NEW/UNUSED CH3353 EXTENSION SETS DID NOT LEAK IN EITHER THE ACTIVATED OR UNACTIVATED POSITIONS. FINAL ANALYSIS SUMMARY: THE COMPLAINT OF SPIROS LEAKAGE WAS CONFIRMED IN THE SINGLE USED CH3353 EXTENSION SET ASSEMBLY. THE LEAKAGE WAS AT THE HALF SEAL IN THE ACTIVATED POSITION. ALTHOUGH THE LOCATION OF THE LEAK IS KNOWN, THE ROOT CAUSE FOR THE LEAKAGE HAS NOT BEEN DETERMINED. PRODUCT RETAINS AND CURRENT PRODUCTION WERE TESTED FOR LEAKS AND NONE WERE FOUND. THIS TYPE OF LEAK IS CONSIDERED TO BE A RARE OCCURRENCE. A MULTI-DISCIPLINE CONTINUOUS IMPROVEMENT TEAM HAS BEEN FORM TO REVIEW AND CHALLENGE THE APPLICABLE DESIGN, MATERIAL AND INVOLVED MANUFACTURING/EQUIPMENT PROCESSES. THIS EVENT HAS BEEN ADDED TO OUR COMPLAINT DATABASE A PART OF OUR TREND ANALYSIS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING "SPIROS LEAKING AT DISTAL END OF CH3353. NURSE NOTICED LEAKING COMING FROM THE CONNECTION OF THE SPIROS AND MC100. NURSE DISCONNECTED FLUSHED THE LINE THEN RECONNECTED THE CH3353 TO THE MC100. SET CONTINUED TO LEAK.: (B)(4) INITIAL 2016-00060" THE NURSE CHANGED OUT THE CH23353 AND NO FURTHER PROBLEMS WERE ENCOUNTERED. UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE CLINICIAN AND PATIENT WERE REPORTED BUT CLEANED PER HOSPITAL PROTOCOL. NO SERIOUS ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING "SPIROS LEAKING AT DISTAL END OF CH3353. NURSE NOTICED LEAKING COMING FROM THE CONNECTION OF THE SPIROS AND MC100. NURSE DISCONNECTED FLUSHED THE LINE THEN RECONNECTED THE CH3353 TO THE MC100. SET CONTINUED TO LEAK.: (B)(4) INITIAL 2016-00060" THE NURSE CHANGED OUT THE CH23353 AND NO FURTHER PROBLEMS WERE ENCOUNTERED. UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE CLINICIAN AND PATIENT WERE REPORTED BUT CLEANED PER HOSPITAL PROTOCOL. NO SERIOUS ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427679 SMALLBORE EXT SET SMALLBORE EXT. SET FPA ICU MEDICAL, INC. CH3353 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1