BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS¿ GP SERIES PRIMARY INFUSION SET

    MDR report key: 17119864 · Received June 13, 2023

    Report

    Report Number
    9616066-2023-01164
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 19, 2023
    Report Date
    May 23, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE (B)(4), IN WHICH THE CUSTOMER HAS INDICATED THAT THEY HAVE FOUND KINKED TUBING IN MULTIPLE 60173E PRODUCTS FROM LOT 1023681. AS PART OF THE INVESTIGATION THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE AFFECTED PRODUCTS; ANALYSIS OF THE PHOTOGRAPHS CONFIRMED THE CUSTOMER'S EXPERIENCE AS A KINK WAS OBSERVED IN THE TUBING BELOW THE DRIP CHAMBER AND ALSO IN THE MIDDLE OF THE LINE. FURTHER ANALYSIS OF THE PHOTOGRAPHS CONFIRMED THAT THE LIKELY CAUSE OF THE KINKED TUBING WAS DUE TO THE TUBING HAVING BEEN COILED OVER THE ORANGE FLOWSTOP COMPONENT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE MOST LIKELY AREA FOR KINKED TUBING TO OCCUR IS DURING THE COILING PROCESS; THIS IS A MANUAL PROCESS PERFORMED IMMEDIATELY PRIOR TO PACKAGING DURING WHICH EACH MODEL CODE IS COILED FOLLOWING A DEFINED PROCEDURE WHICH IS TAILORED TO TAKE INTO ACCOUNT THE COMPONENT CONFIGURATION OF THE PRODUCT. IN THIS INSTANCE IT IS LIKELY THAT THE MANUFACTURING OPERATIVE DID NOT COIL THE SETS IN ACCORDANCE WITH THE CORRECT COILING PROCEDURE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1023681 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT IN ORDER TO BE AWARE OF THE REPORTED FEEDBACK DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH THIS CUSTOMER BEING THE ONLY CUSTOMER TO PROVIDE THIS TYPE OF FEEDBACK AGAINST THE 60173E PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 OF THE ALARIS¿ GP SERIES PRIMARY INFUSION SET WERE KINKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: KINKED TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252649 ALARIS¿ GP SERIES PRIMARY INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1023681

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown