BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 11051756 · Received December 21, 2020

    Report

    Report Number
    8010762-2020-00445
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    December 14, 2020
    Report Date
    December 18, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE "LEAKAGE ON THE PUMP HOUSING IN THE HLS MODULE" WAS DETECTED DURING USE. THE AFFECTED PRODUCT WAS NOT REQUESTED FOR FURTHER INVESTIGATION AS THE FAILURE "LEAKAGE ON THE PUMP HOUSING IN THE HLS MODULE" IS CLEARLY VISIBLE ON THE PROVIDED PICTURES. A SIMILAR CASE WAS ALREADY INVESTIGATED UNDER COMPLAINT #: (B)(4) ON 20209-08-29 WITH THE FOLLOWING RESULT. A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND ON THE PUMP COVER CRACKS WERE DETECTED. A TIGHTNESS TEST ACCORDING TO LV 201 WAS PERFORMED, AND LEAKAGE ON THE CRACKS WERE NOTICED. THE MOST PROBABLE ROOT CAUSE FOR THE LEAKAGE ON THE PUMP HOUSING COULD BE TENSION IN THE MATERIAL BECAUSE NO DAMAGE FROM CAMBER, ETC. COULD BE DETECTED. DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO REFERENCES FOUND, WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. THE REPORTED FAILURE "LEAKAGE ON THE PUMP HOUSING IN THE HLS MODULE" WAS DETECTED DURING USE AND COULD BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CUSTOMER FROM THE U.S. THAT A LEAKAGE ON TH PUMP HOUSING IN THE HLS MODULE WAS DETECTED DURING USE. THE HLS SET WAS REPLACED DURING USE WITH A NEW ONE WITH NOT CONSEQUENCES FOR THE PATIENT. NO INDICATION OF ACTUAL, OR POTENTIAL FOR HARM OR DEATH REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509885 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0 70139157

    Patients

    Seq Age Sex Outcome Treatment
    1