BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SETW/BIOLINE COATING

    MDR report key: 10435840 · Received August 21, 2020

    Report

    Report Number
    8010762-2020-00270
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Date of Event
    August 15, 2020
    Report Date
    October 15, 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 · 0

    THE REPORTED FAILURE "HLS MODULE LEAKING" OCCURRED DURING USE. THE AFFECTED HLS SET WAS REQUESTED FOR FURTHER INVESTIGATION IN THE LABORATORY OF THE MANUFACTURER ON 2020-08-17. THE RETURNED PRODUCT WAS RECEIVED BY THE MANUFACTURER ON 2020-09-01. INVESTIGATION PLAN PREPARED AND FORWARDED TO PEM VIA EMAIL ON 2020-09-07. INVESTIGATION PLAN (V02) RECEIVED AND FORWARDED TO THE LABORATORY ON 2020-09-09. THE AFFECTED PRODUCT WAS INVESTIGATED IN THE LABORATORY ON 2020-10-14. LAB INVESTIGATION RESULTS: A VISUAL INSPECTION WAS PERFORMED. A TIGHTNESS TEST ACCORDING LV 201 WAS PERFORMED. DURING THE VISUAL INSPECTION A CRACK WAS DETECTED IN THE PUMP HOUSING OF THE HLS MODULE. FURTHERMORE A LEAK ON THE DE-AIRING MEMBRANE. DE-AIRING MEMBRANE CLOSED WITH CAP AND THE LEAK ON THE PUMP HOUSING COULD BE CONFIRMED. NO OTHER ABNORMALITIES COULD BE DETECTED. CONCLUSION: THE TIGHTNESS TEST ACCORDING TO LV 201 COULD BE CONFIRM THE REPORTED FAILURE "HLS MODULE LEAKING". LEAKAGE OCCURRED ON THE PUMP HOUSING AND ON THE DE-AIRING MEMBRANE. THE MOST PROBABLE CAUSE FOR THE LEAKAGE ON THE HLS MODULE COULD BE THE DETECTED LEAK ON THE DE-AIRING MEMBRANE AND THE CRACKS ON THE PUMP HOUSING. DEVICE HISTORY RECORD(DHR) WAS PERFORMED AND THERE WERE NO REFERENCES FOUND, WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. THE REPORTED FAILURE "HLS MODULE LEAKING" OCCURRED DURING USE AND COULD BE CONFIRMED. THE DEVICE WAS DIRECTLY INVOLVED IN THE EVENT. 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 · 0

    COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CUSTOMER FROM THE US THAT IN THE HLS MODULE FAILED. THE HLS MODULE STARTED LEAKING BLOOD. BUT THE EXACT POSITION OF THE LEAKAGE IS UNKNOWN. THE PATIENT REMAINED STABLE DURING THE EVENT. CUSTOMER WERE ABLE TO PRIME A NEW HLS SET AND RESTART SUPPORT WITH A NEW CIRCUIT WITHOUT ANY HARM TO THE PATIENT. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902965 HLM TUBING SETW/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0

    Patients

    Seq Age Sex Outcome Treatment
    1