BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPAC IV MONITORING KIT W/ SAFESET MV

    MDR report key: 2040181 · Received March 21, 2011

    Report

    Report Number
    2025816-2010-00119
    Event Type
    Other
    Date Received
    March 21, 2011
    Date of Event
    October 6, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) USED (B)(4), TRANSPEC IV MONITORING KIT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND INVESTIGATION. MFR'S INVESTIGATION: VISUAL INSPECTION AND ANALYSIS WAS PERFORMED. FOLLOWING DECONTAMINATION THE REPORT DOCUMENTED THE TUBING BETWEEN THE KITS TWO VALVES EXHIBITED EVIDENCE OF INDENTATION/KINK AND THAT RESIDUAL BLOOD REMAIN ENTRAPPED INSIDE THE PORT OF THE VALVE. FUNCTIONAL AND PERFORMANCE TESTING WAS PERFORMED. THE RESULTS RECORDED THE RETURNED UNIT/COMPONENTS PASSED LEAK AND OCCLUSION TESTING PER SPECIFICATIONS. ADDITIONAL TESTING AND ANALYSIS WAS CONDUCTED WHERE THE SYRINGE WAS ATTACHED/MATED TO EACH OF THE (B)(4) VALVES. THE RESULTS RECORDED THE VALVES WERE EASILY FLUSHED, FLUID WAS ABLE TO PASS THROUGH WITHOUT RESTRICTIONS. ADDITIONAL ENGINEERING TESTS AND EVALUATIONS WERE PERFORMED TO IDENTIFY CONDITION(S) UNDER WHICH THE (B)(4) VALVES/COMPONENTS WOULD FAIL AND ALLOW FLUID TO OVERCOME THE VALVE AND SPURT THROUGH THE BLUE SILICONE PORT WHEN PRESSURE IS APPLIED FROM THE SIDE PORT(S) OF THE VALVE. THE (B)(4) KITS VALVE IS A PURCHASED COMPONENT. A PROTOCOL UTILIZING THE VENDOR SPECIFICATION DATA WAS DEVELOPED. THE SPECIFICATION STATED THAT THE VALVE SHOULD NOT LEAK WITH A PRESSURE BETWEEN 0 AND 2 BAR. ONE BAR = 14.5 PSI, 2 BAR = 29 PSI. THE VALVES WERE TESTED TO FAILURE. THE TEST RESULTS RECORDED LEAKAGE AT 58 PSI, OR 4 BAR. CONCLUSION: UNABLE TO REPLICATE THE REPORTED PRODUCT EXPERIENCE. TESTING AND ANALYSIS OF THE RETURNED UNIT FOUND NO OUT-OF SPEC CONDITIONS THAT WOULD CONTRIBUTE TO THE PRODUCT EXPERIENCE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING OCCLUSION/FLOW ISSUES WITH ONE (1) (B)(6), TRANSPAC IV MONITORING KIT WITH SAFESET MARVELOUS VALVE 60". THE REPORT STATES THAT "AN RN IN THE MICU WAS ATTEMPTING TO RETURN THE WASTE TO THE PATIENT, BUT APPARENTLY THERE WAS A KINK IN THE ARTERIAL LINE TUBING THAT WAS ALREADY CONNECTED TO THE PATIENT. IT WAS TAKING MORE THAN USUAL EFFORT TO RETURN THE WASTE BLOOD BACK TO THE PATIENT. EFFORTS TO REMEDY FLOW ISSUES WERE UNSUCCESSFUL AS RN ATTEMPTED TO FORCE THE WASTE/FLOW RESULTING IN BLOOD SPURTING/LEAKING OUT OF THE VALVE." THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES, ATTENDING CLINICIAN WAS EXPOSED, EXAMINED AND EXPERIENCED NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPAC IV MONITORING KIT W/ SAFESET MV MONITORING KIT DRS ICU MEDICAL INC. 42644-66 1964174

    Patients

    Seq Age Sex Outcome Treatment
    1