BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5551483 · Received April 6, 2016

    Report

    Report Number
    8010762-2016-00246
    Event Type
    Malfunction
    Date Received
    April 6, 2016
    Date of Event
    March 8, 2016
    Report Date
    May 2, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K090534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE COMPONENT IS A VHK 71000 VENOUS HARDSHELL CARDIOTOMY RESERVOIR; 510(K) #K090534.

    Additional Manufacturer Narrative · 1

    SAMPLE IS NOT AVAILABLE FOR INVESTIGATION, ONLY A PICTURE WAS SENT WITH BROKEN LUER BETWEEN TUBE AND RESERVOIR. THUS THE FAILURE COULD BE CONFIRMED. MOST POSSIBLE ROOT CAUSE COULD NOT BE DETERMINED AS THE FAILURE IS FIRST OF ITS KIND AND CANNOT BE INVESTIGATED. THE SUPPLIER INVESTIGATION SHOWS THAT DEVICE HISTORY RECORD OF THE COMPLAINT LOT HAS BEEN INVESTIGATED AND NO ABNORMALITY WAS FOUND. NO FURTHER INFORMATION COULD BE PROVIDED BY THE (B)(4). THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT, WHEN BEGINNING THE AORTIC ASPIRATION, A JET OF BLOOD WAS OBSERVED. THE LUER BETWEEN THE TUBING AND THE CARDIOTOMY RESERVOIR WAS BROKEN. THE AFFECTED LUER WAS CUT AND THE TUBING CONNECTED TO ANOTHER OUTLET OF THE RESERVOIR. NO CLINICAL CONSEQUENCE WAS REPORTED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208441 HLM TUBING SET W/SOFTLINE COATING CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG HQV 59600

    Patients

    Seq Age Sex Outcome Treatment
    1