BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLENE COATING

    MDR report key: 4995444 · Received August 10, 2015

    Report

    Report Number
    8010762-2015-00882
    Event Type
    Injury
    Date Received
    August 10, 2015
    Date of Event
    August 2, 2015
    Report Date
    August 2, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED TO RETURN TO THE MFR FOR INVESTIGATION. THE PRODUCT WAS NOT REC'D YET. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED, IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INVESTIGATED IN THE LABORATORY OF THE MANUFACTURER. THE VENOUS PRESSURE MEASUREMENT SENSOR WAS FOUND CORRODED. THE PUMPS HOUSINGS CONNECTORS WERE CHECKED FOR TIGHTNESS OF THE MOUNTED O-RINGS, NO ABNORMALITIES WERE FOUND. DURING A TIGHTNESS TEST A LEAKING DE-AIRING MEMBRANE WAS DETECTED. A FUNCTIONALITY TEST WAS PERFORMED AND THE VALUES OF THE PRESSURE MEASUREMENT SYSTEM WERE DISPLAYED ON THE CARDIOHELP MONITOR, ALSO THE PVEN. MOST PROBABLE THE REPORTED FAILURE "VENOUS PRESSURE WAS OUT OF RANGE" WAS CAUSED BY THE CORRODED SENSOR. MOST PROBABLE HUMIDITY LEADS TO THE CORROSION. AN ADDITIONAL COMPLAINT WILL BE OPENED FOR THE UNTIGHT DE-AIRING MEMBRANE IN ORDER TO TRACK AND TREND THIS FAILURE. MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS SHOWING A SIMILAR MALFUNCTION. AN INTERNAL PROCESS (B)(4) WAS INITIATED TO DETERMINE THE MOST PROBABLE ROOT CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF OXYGENATORS IN QUESTION SHOWED THAT THE VENOUS PRESSURE SENSORS ARE PROBABLY CORRODED. A WHITE CRYSTALLINE SUBSTANCE HAS BEEN FOUND ON THE PINS OF THE PRESSURE SENSOR. THE PRIMING SOLUTION LEADS TO AN ELECTROLYSIS WHEN CARDIOHELP STARTS TO WORK. THE ELECTROLYSIS STARTS INSTANTLY AND CAUSES A "SHORT CIRCUIT" BETWEEN THE PINS. THE "SHORT CIRCUIT" FURTHERMORE LEADS TO IMPLAUSIBLE SENSOR PRESSURE READINGS. IT COULD BE SHOWN BY A DRIED ELECTROLYTE PLUG THAT THIS STATE HAS OBVIOUSLY NO IMPACT ON PRESSURE SENSOR READINGS. IT IS OBVIOUS THAT THE ELECTROLYTE (SALINE - PRIMING SOLUTION) ETCHES THE PINS OF THE PLUG. THE MOST PROBABLE ROOT CAUSE IS THAT VARNISH APPLIED ON PCB AND PLUGS OF VENOUS PRESSURE SENSOR DOES NOT RESIST THE ETCHING OF THE SALINE.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "AFTER PRIMING CIRCUIT, CUSTOMER OBSERVED THE VENOUS PRESSURE WAS OBSERVED TO SPIKE EXCEEDINGLY HIGH (+500 MMHG) AND THEN DRIFT DOWN TO A NEGATIVE LEVEL BEYOND ITS RANGE. ALARM "VENOUS PRESSURE OUT OF RANGE" IS CONTINUOUSLY ACTIVATED. NO OTHER PRESSURES ARE AFFECTED CUSTOMER USED ANOTHER CONSOLE AND CABLE TO CHECK THE STATUS OF THE CONNECTION. DIFFERENT CONSOLE GAVE THE SAME READINGS AND INFORMATION - VENOUS PRESSURE OUT OF RANGE BUT NOT OTHER PRESSURES WERE AFFECTED. CUSTOMER HAS NOT CHOSEN TO REPLACE THE CIRCUIT BECAUSE OF THE UNSTABLE NATURE OF THE PATIENT." (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522694 HLM TUBING SET W/BIOLENE COATING DWE MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA 70105877

    Patients

    Seq Age Sex Outcome Treatment
    1 Other