BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL MONITORING KIT

    MDR report key: 4994611 · Received August 10, 2015

    Report

    Report Number
    2025816-2015-00093
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    February 23, 2015
    Report Date
    March 19, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT #2963371 (MFG. 11/2014) SHOWED (B)(4) UNITS WERE MFG., TESTED INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. A REVIEW OF THE COMPLAINT DATA FOR THIS LIST #, LOT # AND SIMILAR ISSUE RECORDED NO ADDITIONAL REPORTS. FINDINGS: THE INVOLVED (B)(4) DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE(S) OF THE REPORTED EVENT/PRODUCT ISSUE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION (PRE AND POST DECONTAMINATION) WAS PERFORMED. THE REPORT NOTED THAT DURING DECONTAMINATION FLUSHING LEAKAGE WAS OBSERVED AT THE BONDING SITE OF THE TRANSDUCER AND THE SQUEEZE FLUSH. IT WAS ALSO NOTED THAT THERE WERE SEVERAL MINOR CRACKS AT THE TOP OF THE FEMALE LUER NEAR THE SQUEEZE FLUSH. HOWEVER, THERE WAS NO LEAKAGE ORIGINATING FROM THESE COMPONENT CRACKS. ENGINEERING TESTING AND EVALUATION OF THE RETURNED PARTIAL 46094-31 MONITORING KIT RECORDED THE LEAKAGE WAS DUE TO AN ASSEMBLY BONDING ERROR (INSUFFICIENT SOLVENT BOND). TREND AND LOT RECORD REVIEWS: A REVIEW OF THE MFG. IN-PROCESS LOT BUILD RECORDS AND TREND REPORTS SHOWED THIS TO BE A VERY UNUSUAL OCCURRENCE. FINDINGS: THE REPORTED PRODUCT ISSUE WAS CONFIRMED. THE ROOT CAUSE WAS DUE TO AN INSUFFICIENT SEAL BETWEEN THE TRANSDUCER AND SQUEEZE FLUSH BOND. ICU MEDICAL WILL MONITOR AND TREND THE FAILURE MODE.

    Description of Event or Problem · 1

    MAUDE REPORT RECEIVED CONCERNING LEAKAGE ISSUE WITH USE OF (B)(4) NEONATAL MTG. KIT. MW (B)(4) DESCRIBES THE EVENT AS FOLLOWS ".. PT. REQUIRED UAC LINE FOR FLUIDS AND MONITORING WHILE IN NEONATAL ICU. RN NOTICED THE UAC LINE WAS LEAKING FLUIDS ABOVE THE YELLOW PLASTIC PIECE ON THE TRANSDUCER TUBING. LINE TEAM NOTICED A SMALL AMOUNT OF FLUID LEAKING FROM TIP OF THE SYRINGE AS THE SEAL ON THE TUBING WOULD NOT FORM BETWEEN THE SYRINGE AND THE TUBING WHEN THE SYRINGE WAS SCREWED ON PROPERLY. PLASTIC MALE TIP ON THE LINE HAD BROKEN OFF. FOLLOW UP WITH THE FACILITY FOR ADDITIONAL RELEVANT SET-UP/USAGE INFORMATION AND DEVICE RETURN STATUS AS OF THE DATE OF THIS REPORT HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: DEVICE RETURN: RECEIVED ONE USED "PARTIAL" 46094-31 NEONATAL MTG. KIT. THE MTG. KIT STOPCOCK SEGMENT WAS NOT RETURNED; ONE 3ML SALINE SYRINGE. THIS IS THE MFGER'S FOLLOW UP REPORT TO PROVIDE THE DEVICE RETURN INVESTIGATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521868 NEONATAL MONITORING KIT MONITORING KIT FPA ICU MEDICAL, INC. 46094-31 2963371

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA