BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON VENTED HIGH VOL.INLET,N/S

    MDR report key: 10455210 · Received August 26, 2020

    Report

    Report Number
    1416980-2020-05205
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO D10, H3, H4 AND H6. H4: THE POTENTIAL LOT NUMBER 802869 MANUFACTURED DATE IS AUGUST 21, 2019. H4: THE POTENTIAL LOT NUMBER 802858 MANUFACTURED DATE IS JULY 15, 2019. H10: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. UNAIDED VISUAL INSPECTION WAS PERFORMED WHICH OBSERVED THAT THE SPIKE WAS DETACHED FROM THE TUBING. DUE TO THE NATURE OF THE RETURNED SAMPLE, NO ADDITIONAL TESTING COULD BE PERFORMED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS NOT DETERMINED; HOWEVER, THE MOST LIKELY CAUSE WAS DUE TO INADEQUATE OR LACK OF CYCLOHEXANONE BEING APPLIED TO THE SPIKE OR TUBING IN THE MANUFACTURING PROCESS. 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

    LOT # AND EXPIRATION DATE: THE LOT # IS EITHER 802869 (EXPIRATION DATE: 07/04/2022) OR 802858 (EXPIRATION DATE: 06/06/2022). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTOR SPIKE OF A NON-VENTED HIGH-VOLUME INLET WAS LOOSE AND BECAME DETACHED EASILY. IT WAS FURTHER REPORTED THAT THE "LEAD CAME OFF THE SPIKE WHILE THE SPIKE WAS STILL ATTACHED" TO AN AMINO ACID CONTAINER. THIS WAS IDENTIFIED IN THE FILL ROOM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918756 NON VENTED HIGH VOL.INLET,N/S SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1