BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OM-10000

    MDR report key: 9566221 · Received January 8, 2020

    Report

    Report Number
    2242352-2020-00033
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 17, 2019
    Report Date
    March 6, 2020
    Manufacturer
    MAQUET (SUZHOU) CO.,LTD.
    Product Code
    MWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY ON 01/09/2020. AN INVESTIGATION WAS CONDUCTED ON 03/04/2020. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE BLUE SUCTION CONNECTOR WAS OBSERVED TO BE DETACHED FROM THE DEVICE. IT WAS RETURNED FOR EVALUATION. NO OTHER VISUAL DEFECTS WERE OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE "BREAK" WAS CONFIRMED. THE DHR, SHOP FLOOR PAPERWORK WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: H-3 (DEVICE NOT EVAL PROVIDE CODE). TRACKWISE ID# (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    TRACKWISE ID # (B)(4). CORRECTED SECTION: G-1 CONTACT OFFICE: CORRECTED FROM "MAQUET (SUZHOU) CO., LTD" TO "MAQUET CARDIOVASCULAR LLC."

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER SUCTION CONNECTOR BROKE OFF UPON CONNECTING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER SUCTION CONNECTOR BROKE OFF UPON CONNECTING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER SUCTION CONNECTOR BROKE OFF UPON CONNECTING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID #(B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR¿S FOR THE REPORTED LOT NUMBER. THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER SUCTION CONNECTOR BROKE OFF UPON CONNECTING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28617 OM-10000 STABILIZER, HEART MWS MAQUET (SUZHOU) CO.,LTD. OM-10000 25147609

    Patients

    Seq Age Sex Outcome Treatment
    1