BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEE SECTION H11

    MDR report key: 21702096 · Received March 26, 2025

    Report

    Report Number
    9617594-2025-00562
    Event Type
    Death
    Date Received
    March 26, 2025
    Date of Event
    February 12, 2025
    Report Date
    June 30, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709068193
    PMA / PMN Number
    K100576
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED FOUR (4) USED A1129 SMALLBORE PRESSURE INFUSION (400PSIG) EXT SETS AND ONE (1) USED LIST#: UNKNOWN CATHETER MATED TO ONE (1) OF THE SETS FOR INSPECTION. A CRACK WAS OBSERVED ON THE FEMALE LUER ON THREE (3) OF THE A1129 SETS. A CRACK WAS OBSERVED ON THE CATHETER MATED TO THE ONE (1) USED SET WITH NO CRACK. EACH SET WAS LEAK TESTED PER PRODUCT SPECIFICATIONS. THERE WAS LEAKAGE FROM THE CRACKS ON EACH SET. THE REPORTED COMPLAINT CAN BE CONFIRMED ON THREE (3) OF THE RETURNED USED A1129 SETS. THE PROBABLE CAUSE OF THE CRACK AND SUBSEQUENT LEAKAGE IS DUE TO A MATERIAL ISSUE ON A VENDOR SUPPLIED PART. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED ON THE ONE (1) USED A1129 MATED TO THE LIST#: UNKNOWN CATHETER. THE CRACK AND SUBSEQUENT LEAKAGE WAS ON A NON-ICU MEDICAL PART. THERE WERE NO DEFECTS OR ANOMALIES ON THE A1129. THE REPORTED LOT HISTORY AND A LOT OF THE PACKAGING WAS REVIEWED; NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. CORRECTIVE ACTIONS ARE IN PROCESS. ADDITIONAL INFORMATION IN B5. D9 DEVICE RETURNED TO MANUFACTURER ON 3/6/2025.

    Additional Manufacturer Narrative · 0

    SECTION D1 - BRAND NAME: 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, NANOCLAVE® T-CONNECTOR (PURPLE RING), ROTATING LUER. THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION, HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING 2 T-CONNECTORS STARTED LEAKING WITH ADMINISTRATION OF RAPID BLOOD ADMINISTRATION, AND T-CONNECTOR STARTED LEAKING WITH ADMINISTRATION OF FLUSH.

    Description of Event or Problem · 0

    THE EVENT INVOLVED 4 INCIDENTS WHERE THE 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, NANOCLAVE® T-CONNECTOR (PURPLE RING), ROTATING LUER DEVICES LEAKED DURING PATIENT ADMINISTRATION OF EMERGENCY MEDICATION/RAPID BLOOD ADMINISTRATION ON THE SAME PATIENT. THE PATIENT EXPIRED. THE CUSTOMER FURTHER REPORTED THAT IT WAS UNCLEAR IF THE CONNECTOR COULDN'T HANDLE THE PRESSURE FROM THE RAPID FLUID DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559389 SEE SECTION H11 SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14144054 00887709068193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death UNSPECIFIED MEDICATION, MFR UNK.