BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SPIROS

    MDR report key: 23226363 · Received October 6, 2025

    Report

    Report Number
    9617594-2025-01953
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG ON 10/13/2025. RECEIVED ONE (1) USED. LIST #UNKNOWN, SPIROS; LOT #UNKNOWN. ---> ONE (1) USED. LIST #UNKNOWN, NEOPUMP-R; LOT #241894. ---> ONE (1) USED. LIST #UNKNOWN, CHEMOLOCK PORT; LOT #UNKNOWN. THE SPIN COLLAR WASN'T ACTIVATED. DAMAGE TO THE SPIROS STRAP WAS ALSO OBSERVED CAUSING THE POPPIT TO STAY OPEN. THE REPORTED COMPLAINT OF A LEAK COULD BE CONFIRMED. THE SAMPLE WAS OBSERVED TO HAVE DAMAGE ON THE SPIROS STRAP CAUSING THE POPPIT TO STAY OPEN. THE PROBABLE CAUSE IS FROM A LEAK ONTO THE SPIROS STRAP. HOW THE LEAK OCCURRED IS UNKNOWN.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN UNSPECIFIED SPIROS MALFUNCTION. IT WAS REPORTED WHEN CONNECTED TO A PORTABLE DIFFUSER, LIQUID LEAKS OUT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279257 UNSPECIFIED SPIROS SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PORTABLE DIFFUSER, UNK MFR| VIDAZA, UNK MFR