BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SET, STD VOL, STER

    MDR report key: 11592559 · Received March 30, 2021

    Report

    Report Number
    1416980-2021-01715
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    NEP
    UDI-DI
    00085412475721
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B4/F8: DATE OF THIS REPORT IN THE INITIAL MDR IS BEING CORRECTED FROM BLANK TO (B)(6) 2021.

    Additional Manufacturer Narrative · 0

    LOT MANUFACTURED BETWEEN DECEMBER 19, 2018 TO DECEMBER 20, 2018. THE DEVICE EVALUATION WAS COMPLETED. VISUAL INSPECTION OF THE DEVICE WAS PERFORMED WHICH OBSERVED A DAMAGED SECTION APPROXIMATELY 1.50 INCHES IN LENGTH (TEAR/HOLE) AT THE MIDDLE AREA OF THE SILICONE TUBING. FUNCTIONAL REPEATER PUMP TESTING WAS PERFORMED WITH STERILE WATER WHICH REVEALED A LEAK ONLY FROM THE MIDDLE DAMAGED SECTION OF THE SILICONE TUBING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE TEAR/HOLE COULD NOT BE DETERMINED; HOWEVER POSSIBLE CAUSE OF DAMAGE TO THE SILICONE TUBING MOST LIKELY OCCURRED FROM REPEATER PUMP ROTOR IMPACT. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET BROKE DURING USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488395 TUBE SET, STD VOL, STER SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE CORPORATION NA 60164203 00085412475721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA.