BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 10527713 · Received September 14, 2020

    Report

    Report Number
    9617594-2020-00382
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 19, 2020
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE LOT NUMBER: 4764633, EXP. DATE 03/01/2025, MFG DATE 03/01/2020. RECEIVED ONE USED LIST# 20130-01, SPINNING SPIROS ® CLOSED MALE LUER, RED CAP. LOT# 4764633 AND ONE (1) USED TUBING & EQUASHIELD FEMALE CONNECTOR. NO LEAKAGE WAS DETECTED AT ANY LOCATION ALONG THE FLUID PATH. THE USED 20130-01 SPINNING SPIROS WAS DISCONNECTED FROM THE UNIDENTIFIED PUMP SET, AND PRESSURE LEAK TESTED USING AN AUXILIARY TEST AT 7 PSI WHILE APPLYING LIGHT BENDING/ROTATING FORCES THAT WOULD BE TYPICAL OF USE. LEAKAGE WAS OBSERVED WHILE ACTIVATED WITH THE EQUASHIELD CONNECTOR, AND WHEN THE EQUASHIELD CONNECTOR WAS REMOVED AND THE USED 20130-01 SPINNING SPIROS WAS IN THE UNACTIVATED POSITION. THE LEAKAGE WAS OBSERVED AT THE POPPET/O-RING INTERFACE. THE LEAKAGE FROM THE USED 20130-01 SPINNING SPIROS WAS CONFIRMED. THE PROBABLE CAUSE OF THE LEAKING SPIROS IS DUE TO A MOLDING ANOMALY ON THE SEALING SURFACE OF THE POPPET SUB-COMPONENT. A DEVICE HISTORY REVIEW DHR LOT# 4764633 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT THE CUSTOMER REPORTED FLUOROURACIL LEAKING OUT OF THE SPIROS. THE ISSUE WAS FOUND WHEN THE PATIENT CAME FOR REMOVAL OF THE PUMP. THE SET UP WAS AN UNSPECIFIED TUBING SET ATTACHED WITH AN UNSPECIFIED PUMP TO AN EQUASHIELD FEMALE CONNECTOR FOR A NEEDLE FREE CONNECTION TO THE PATIENT. WHITE RESIDUE WAS SEEN ON THE SPIROS, AND ON THE PATIENT'S ARM. THE AREA AND THE PATIENT'S ARM WAS CLEANED APPROPRIATELY. THERE WAS NO REPORTED IMPACT TO THE PATIENT, AND THE AMOUNT THAT LEAKED OUT WAS NOT LARGE. THE PUMP'S CARRYING CASE WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE EVENT. THIS REPORT CAPTURES THE FIRST OF FOUR INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996226 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOT

    Patients

    Seq Age Sex Outcome Treatment
    1 CONNECTOR, EQUASHIELD MFR| FLUOROURACIL, UNK MFR| UNSPECIFIED INFUSION PUMP| UNSPECIFIED TUBING SET