BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ PUMP MODULE ADMINISTRATION SET

    MDR report key: 12652397 · Received October 18, 2021

    Report

    Report Number
    9616066-2021-52250
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 20, 2021
    Report Date
    October 22, 2021
    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
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH POSSIBLE LOT NUMBERS: D4: MEDICAL DEVICE LOT #: 21056177. D4: MEDICAL DEVICE EXPIRATION DATE: 2024-05-20. H4: DEVICE MANUFACTURE DATE: 2021-05-20. D4: MEDICAL DEVICE LOT #: 21056047. D4: MEDICAL DEVICE EXPIRATION DATE:2024-05-19. H4: DEVICE MANUFACTURE DATE: 2021-05-19. D4: MEDICAL DEVICE LOT #: 21056048. D4: MEDICAL DEVICE EXPIRATION DATE: 2024-05-20. H4: DEVICE MANUFACTURE DATE: 2021-05-20. D4: MEDICAL DEVICE LOT #: 21056178. D4: MEDICAL DEVICE EXPIRATION DATE: 2024-05-19. H4: DEVICE MANUFACTURE DATE: 2021-05-19. H6: INVESTIGATION SUMMARY ONE 2401-0004 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; HOWEVER A REVIEW OF THE LASER ID FROM THE SMARTSITE COMPONENT CONFIRMED A POSSIBLE LOT NUMBER TO BE EITHER 21056177, 21056047, 21056048 OR 21056178. FLUID WAS PRESENT THROUGHOUT THE LINE. INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT THE CUSTOMER'S EXPERIENCE WAS IDENTIFIED DURING INFUSION. A VISUAL INSPECTION CONFIRMED THE CUSTOMER'S EXPERIENCE AS A SMALL HOLE WAS IDENTIFIED IN THE SILICONE TUBING NEAR THE UPPER PUMPING SEGMENT COMPONEN; LEAKAGE WAS OBSERVED FROM THE HOLE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED DAMAGE COULD NOT BE DETERMINED IN THIS INSTANCE, HOWEVER AS THE LEAKAGE WAS OBSERVED DURING INFUSION AND NOT DURING PRIMING, IT IS UNLIKELY THAT A MANUFACTURING DEFECT CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 21056177, 21056047, 21056048 OR 21056178 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN 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 AN ISOLATED FEEDBACK WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE 2401-0004 PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED BD ALARIS¿ PUMP MODULE ADMINISTRATION SET WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAK AT TOP OF SILICONE TUBING NOTED DURING INFUSION. ON INVESTIGATION VERY TINY HOLE FOUND."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER ZIP: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BD ALARIS¿ PUMP MODULE ADMINISTRATION SET WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAK AT TOP OF SILICONE TUBING NOTED DURING INFUSION. ON INVESTIGATION VERY TINY HOLE FOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546455 BD ALARIS¿ PUMP MODULE ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown