BEUDAMED
    FDA Adverse Event Death Summary report: N

    SORIN HEATER-COOLER SYSTEM 3T

    MDR report key: 6123292 · Received November 22, 2016

    Report

    Report Number
    9611109-2016-00775
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    April 17, 2015
    Report Date
    August 10, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K052601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A COMPLAINT REVIEW CONDUCTED ON JULY 13, 2107, IT WAS DISCOVERED THAT THIS ISSUE WAS REPORTED BY MULTIPLE FACILITIES, AS THE SURGERY AND DEATH DID NOT OCCUR AT THE SAME HOSPITAL. IN ADDITION TO (B)(6) HOSPITAL, WHO WAS DOCUMENTED ON THE INITIAL REPORT AND FOLLOW-UP 1, THE ISSUE WAS ALSO REPORTED BY (B)(6) HOSPITAL (WHERE THE DEATH OCCURRED) ON USER MEDWATCH REPORT MW5066126 AND ON THE MANUFACTURER REPORT 9611109-2016-00887. THE MANUFACTURER REPORT 9611109-2016-00887 HAS NOW BEEN VOIDED AS A DUPLICATE AND ALL DETAILS REPORTED BY THE TWO FACILITIES ARE NOW DOCUMENTED IN THIS REPORT (9611109-2016-00775; SEE BELOW). DATE OF DEATH: (B)(6) 2016. EVENT DESCRIPTION AS REPORTED BY HOSPITAL WHERE DEATH OCCURRED: ON NOVEMBER 28, 2016, LIVANOVA (B)(4) RECEIVED A USER MEDWATCH REPORT (MW5066126) STATING THAT A PATIENT PRESENTED WITH A NON-TUBERCULOUS MYCOBACTERIUM INFECTION AFTER UNDERGOING CARDIAC BYPASS SURGERY A YEAR PRIOR AT A DIFFERENT FACILITY. THE PATIENT DIED FROM THE COMPLICATIONS OF THE INFECTION. (B)(6). ADDITIONAL MANUFACTURER NARRATIVE REGARDING INFORMATION PROVIDED BY HOSPITAL WHERE DEATH OCCURRED: THROUGH FOLLOW-UP COMMUNICATION WITH THE (B)(6), LIVANOVA (B)(4) LEARNED THAT THE PATIENT WAS ADMITTED TO THE (B)(6) ON (B)(6) 2016, WHERE A COMPLICATED WASHOUT/DEBRIDEMENT OF THE MEDIASTINAL INFECTION WAS PERFORMED. THE PATIENT DIED ON (B)(6) 2016 AT THE AGE OF (B)(6).

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). ADDITIONAL FOLLOW-UP COMMUNICATION WITH THE CUSTOMER CONFIRMED THAT THEY STILL DO NOT HAVE ANY FURTHER INFORMATION AVAILABLE RELATED TO THE INVOLVED DEVICE(S) OR THE PATIENT. NO DEVICE ISSUE HAS BEEN ALLEGED OR CONFIRMED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE USER MEDWATCH REPORT LISTS THE DATE OF DEATH AS (B)(6) 2016. HOWEVER, THE DESCRIPTION STATES THAT THE PATIENT DIED IN FALL 2016. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER CONFIRMED THAT THE PATIENT DIED IN 2016. THE EXACT DATE WAS NOT AVAILABLE. THE USER MEDWATCH REPORT LISTS 3 SERIAL NUMBERS (ALL (B)(4)). IT IS UNKNOWN WHICH DEVICE WAS USED ON THE PATIENT. (B)(4). DEVICE MANUFACTURE DATE (MM/DD/YYYY): (B)(4)- 12/17/2009; (B)(4)- 04/02/2012; (B)(4)- 11/15/2012. SORIN GROUP DEUTSCHLAND MANUFACTURES THE SORIN HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN ST. PAUL, MINNESOTA. THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP DEUTSCHLAND. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER ON NOVEMBER 17, 2016, THE CONTACT STATED THAT THE EXACT DATE OF DEATH WAS NOT PROVIDED TO HER. THE PATIENT DID NOT DIE AT REGIONS HOSPITAL IN ST. PAUL, MN. THE CUSTOMER BELIEVES THE PATIENT DIED SOME TIME IN 2016. THE CUSTOMER ALSO STATED THAT ALL THREE UNITS IN USE AT THE FACILITY AT THE TIME OF THE PROCEDURE HAVE BEEN REMOVED FROM SERVICE. THE CONTACT WAS NOT AWARE OF ANY BACTERIAL TESTING OF THE DEVICES AND DID NOT KNOW IF UNITS WERE PLACED INSIDE OR OUTSIDE THE OPERATING ROOM DURING USE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ON OCTOBER 27, 2016, SORIN GROUP (B)(4) RECEIVED A USER MEDWATCH REPORT ((B)(4)) STATING THAT A PATIENT DIED AFTER BEING DIAGNOSED WITH A MYCOBACTERIUM CHIMAERA INFECTION. THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE, AORTIC VALVE REPLACEMENT, AND ABDOMINAL AORTIC ANEURYSM REPAIR IN 2015. THE PROCEDURE INVOLVED THE USER OF A SORIN HEATER-COOLER SYSTEM 3T. THE PATIENT DID WELL WITH THE SURGERY AND POST-OPERATIVELY. IN 2016, THE HOSPITAL (REGIONS HOSPITAL IN ST. PAUL, MN) RECEIVED A NOTIFICATION THAT THE PATIENT WAS DIAGNOSED WITH AN M. CHIMAERA INFECTION AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774068 SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death