BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP-I

    MDR report key: 10031705 · Received May 7, 2020

    Report

    Report Number
    8010762-2020-00152
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 21, 2020
    Report Date
    June 26, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOG FILES WERE ANALYZED BY THE TECH SUPPORT ON 2020-04-30. ACCORDING TO THE ANALYSIS THE PUMP DISPOSABLE ERROR CAN BE CONFIRMED. THE CAUSE OF THE DISPOSABLE ERROR IS WHEN THE DISPOSABLE WILL BE DISCONNECTED FROM THE CARDIOHELP DURING PUMP IS RUNNING. SECOND CAUSE COULD BE WHEN USING ANOTHER HLS SET WITHOUT SETTING THE PUMP TO ZERO. NO FURTHER FAILURES COULD BE CONFIRMED ACCORDING TO THE LOG FILES. THUS A FAILURE RELATED TO THE CARDIOHELP CAN BE EXCLUDED. THE DHR OF THE CARDIOHELP (MATERIAL: 70104.8012, SERIAL: (B)(6)) FOR WHICH A CUSTOMER COMPLAINT WAS RECEIVED, WAS REVIEWED ON 2020-05-11. THE DHR DOES NOT SHOW ANY ABNORMALITY OR ISSUE THAT IS RELATED OR CAN HAVE LED TO THE CUSTOMER COMPLAINT. THE DHR OF THE BEQ-015703112#HLS MODULE ADVANCE ADULT (MATERIAL#70105.4379, LOT#70130454, SERIAL# (B)(6)) FOR WHICH A CUSTOMER COMPLAINT WAS RECEIVED, WAS REVIEWED ON 2020-05-12. THE AVZ FROM (B)(6) (PRODUCTION LOT#70130004, DMS#2765054) DOES NOT SHOW ANY ABNORMALITY OR ISSUE THAT IS RELATED OR CAN HAVE LED TO THE CUSTOMER COMPLAINT. THE CARDIOHELP WAS CHECKED BY A GETINGE TECHNICIAN ON 2020-05-27. NO MALFUNCTION OR AN ABNORMALITY COULD BE FOUND. REGARDING THE INVOLVED DISPOSABLE THE FAILURE WAS ALREADY INVESTIGATED IN SEVERAL OTHER COMPLAINTS (B)(4). IN ALL CASES NO FAILURE COULD BE FOUND. THUS THE REPORTED FAILURE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    A GETINGE TECHNICIAN CHECKED THE ABOVE CARDIOHELP (SERIAL NUMBER 90412427) ON 2020-05-27. THE REPORTED FAILURE COULD NOT BE REPRODUCED NOR CONFIRMED. THE LOG FILES OF THE CONCERNED CARDIOHELP WERE ANALYZED BY A GETINGE TECHNICIAN ON 2020-04-30. ACCORDING TO THE ANALYSIS THE ERROR MESSAGE ¿PUMP DISPOSABLE ERROR¿ COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THE PUMP DISPOSABLE ERROR IS WHEN THE DISPOSABLE IS BEEN DISCONNECTED FROM THE CARDIOHELP DURING THE PUMP IS RUNNING. A FURTHER CAUSE COULD BE WHEN THE USER DOES NOT SET THE PUMP TO ZERO BEFORE CONNECTING THE DISPOSABLE (REFER TO THE INSTRUCTION FOR USE OF HLS SET, CHAPTER 5.3.1). DUE TO THIS CONCLUSION THE MALFUNCTION RELATED TO THE CARDIOHELP CANNOT BE CONFIRMED. THE DHR OF THE CARDIOHELP (MATERIAL: 70104.8012, SERIAL: 90412427) FOR WHICH A CUSTOMER COMPLAINT WAS RECEIVED, WAS REVIEWED ON 2020-05-11. THE DHR DOES NOT SHOW ANY ABNORMALITY OR ISSUE THAT IS RELATED OR CAN HAVE LED TO THE CUSTOMER COMPLAINT. THE DHR OF THE BEQ-015703112#HLS MODULE ADVANCE ADULT (MATERIAL#70105.4379, LOT#70130454, SERIAL# 1342398) FOR WHICH A CUSTOMER COMPLAINT WAS RECEIVED, WAS REVIEWED ON 2020-05-12. THE AVZ (LIST OF WORK STEPS) FROM 1342396 TO 1342405 (PRODUCTION LOT#70130004, DMS#2765054) DOES NOT SHOW ANY ABNORMALITY OR ISSUE THAT IS RELATED OR CAN HAVE LED TO THE CUSTOMER COMPLAINT. THE CARDIOHELP RISK ANALYSIS VERSION 21 (DMS# 2021972) WAS REVIEWED ON 2020-04-29 AND THE REPORTED FAILURE ¿PUMP DISPOSABLE ERROR¿ IS COVERED IN SECTION H1.1.1.3 (HAZARD: NO OR TOO LOW BLOOD FLOW) THE THE REPORTED FAILURE COULD BE CONFIRMED BUT IT WAS NO PRODUCT RELATED MALFUNCTION. THE MOST PROBABLE ROOT CAUSE OF THE PUMP DISPOSABLE ERROR IS WHEN THE DISPOSABLE IS BEEN DISCONNECTED FROM THE CARDIOHELP DURING THE PUMP IS RUNNING. A FURTHER CAUSE COULD BE WHEN THE USER DOES NOT SET THE PUMP ZU ZERO BEFORE CONNECTING THE DISPOSABLE. 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.

    Description of Event or Problem · 0

    COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    COMPLAINT NUMBER: (B)(4). AS STATED BY THE CUSTOMER: WE HAVE HAD A CARDIOHELP FAILURE ON A PATIENT ON TUESDAY APRIL 21. THE FAILURE OCCURRED ON THE SAME HARDWARE THAT WE HAD FLOW PROBE ISSUES WITH IN THE SUMMER OF LAST YEAR (S/N (B)(4)). WE HAVE A NEW FLOW PROBE ON THE UNIT. THIS UNIT FAILED WHILE A PATIENT WAS HAVING A CT SCAN AND WE WERE NOT ABLE TO FLOW. THE NEGATIVE PRESSURE WAS VERY NEGATIVE -250 AND THE FLOW WAS ZERO. WE CHECKED THE CANNULAS AND HAD NO KINKS AND EVEN WITH ZERO RPMS WE HAD A NEGATIVE PRESSURE OF -100 AND COULD NOT GET ANY FORWARD FLOW. WE ALSO DID A FLUID RESUSCITATION. WE THEN HAD TO HAND CRANK. WE CT SCANNED THE PATIENT WHILE HAND CRANKING AND THERE WAS NO ISSUE WITH THE CANNULA. WHEN WE TRIED TO PUT THE DISPOSABLE BACK INTO THE DRIVE UNIT THE ERROR CODE SAID ¿DISPOSABLE FAILURE-STOP¿ AT THIS TIME WE COULDN¿T USE GLOBAL OVERRIDE TO RESTART THE PUMP. ON THE THIRD ATTEMPT THE DISPOSABLE FAILURE ALARM DIDN¿T APPEAR AND GLOBAL OVERRIDE WORKED. WE WERE ABLE TO RE-ESTABLISH FLOW AND GET BACK TO THE ICU. WE CHANGED UNITS IN THE ICU AND HAVE NOT HAD AN ISSUE SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497361 CARDIOHELP-I CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH 701048012 - CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other