BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATSMART

    MDR report key: 10364361 · Received August 4, 2020

    Report

    Report Number
    3004634229-2020-00001
    Event Type
    Death
    Date Received
    August 4, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 10, 2020
    Manufacturer
    FRESENIUS HEMOCARE GMBH
    Product Code
    CAC
    PMA / PMN Number
    K160735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    DEATH OF A PATIENT ALLEGED DEFICIENCY DESCRIPTION: CUSTOMER WAS CELL SAVING FOR A TRIPLE A CASE AT 10:00PM, PRIMED MACHINE AS USUAL - STARTED AND PROCESSED 300ML DURING CASE THEN DEVICE STARTED ALARMING . RECEIVED PRC FAILURE, SALINE ERROR, AND HIGH VOLTAGE ERROR. CHECKED ALL CLAMPS AND OPENED LID TO MAKE SURE NO ISSUES, ADJUSTED TUBING INSIDE DEVICE. RECEIVING A LOT OF BLOOD BACK - STOPPED AND RESTARTED MACHINE FOR MINUTES MAYBE 1-2, 1200+ ML IN RESERVOIR. PER EMAIL FROM SR. CATS MARKETING MANAGER ON(B)(6)2020 I SPOKE WITH (B)(6) (TERUMO REP) AND ACCORDING TO THE TECH AND THE CHIEF OF PERFUSION- THE PERFUSION GROUP IS NOT BLAMING THE DEVICE FOR THE DEATH AS WHEN THEY WENT IN THINGS WERE NOT GOOD AND FOR THE MOST PART UNREPAIRABLE. THEY DO HAVE CONCERNS WITH THE DEVICE FOR THE ALARMS THAT TOOK PLACE DURING THIS TIME. THE RCC BAG IS USED TOGETHER WITH A CUFF. THE PATIENT IS CONNECTED DIRECTLY TO THE RCC BAG. THE RED CELLS ARE RETURNED TO THE PATIENT BY PRESSURE. THIS IS NOT THE INTENDED USE. AFTER CELL COLLECTION THE RCC BAG MUST BE REMOVED FROM THE SYSTEM AND THE RED CELLS MUST BE RETURNED TO THE PATIENT BY GRAVITY. PROBABLE ERROR DURING THIS EVENT : · USER INFLATES CUFF TO RETURN CELLS TO PATIENT · USER CLOSES CLAMP ON PATIENT LINE AND FORGETS TO DEFLATE THE CUFF · DEVICE IS NOT ABLE TO PUMP RED CELLS INTO THE BAG AGAINST THE CUFF PRESSURE HUMAN FAULT. RESULT OF RISK ASSESSMENT: THE ISSUE WAS CAUSING A POSSIBLE DELAY IN PROCESSING: REFERRING TO THE RISK ANALYSIS, THE CASE CAN BE DEFINED BY THE HARM: "INSUFFICIENT PATIENT CARE (NO OR IMPAIRED TRANSFUSION PRODUCT)", THAT IS RATED WITH A SEVERITY OF (B)(4) (NEGLIGIBLE). IN CONJUNCTION WITH THE CSO, THE COMPLAINT WAS ASSESSED AS "NO ESCALATION TO LEVEL 2" AFTER THE MDR REPORTABILITY ASSESSMENT.

    Description of Event or Problem · 1

    DEATH OF A PATIENT ALLEGED DEFICIENCY DESCRIPTION: CUSTOMER WAS CELL SAVING FOR A TRIPLE A CASE AT 10:00PM, PRIMED MACHINE AS USUAL - STARTED AND PROCESSED 300ML DURING CASE THEN DEVICE STARTED ALARMING . RECEIVED PRC FAILURE, SALINE ERROR, AND HIGH VOLTAGE ERROR. CHECKED ALL CLAMPS AND OPENED LID TO MAKE SURE NO ISSUES, ADJUSTED TUBING INSIDE DEVICE. RECEIVING A LOT OF BLOOD BACK - STOPPED AND RESTARTED MACHINE FOR MINUTES MAYBE 1-2, 1200+ ML IN RESERVOIR. PER EMAIL FROM SR. CATS MARKETING MANAGER ON 7/10/2020: I SPOKE WITH (B)(6) (TERUMO REP) AND ACCORDING TO THE TECH AND THE CHIEF OF PERFUSION- THE PERFUSION GROUP IS NOT BLAMING THE DEVICE FOR THE DEATH AS WHEN THEY WENT IN THINGS WERE NOT GOOD AND FOR THE MOST PART UNREPAIRABLE. THEY DO HAVE CONCERNS WITH THE DEVICE FOR THE ALARMS THAT TOOK PLACE DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828908 CATSMART CATSMART CAC FRESENIUS HEMOCARE GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death