BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 4898953 · Received June 30, 2015

    Report

    Report Number
    9611109-2015-00211
    Event Type
    Other
    Date Received
    June 30, 2015
    Report Date
    June 3, 2015
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    UNK
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF SORIN HEATER COOLER DEVICES. THE Z NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN HEATER-COOLER SYSTEM 3T MACHINE TESTED POSITIVE FOR MYCOBACTERIA DURING MAINTENANCE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. A VISUAL INSPECTION OF THE OUTER AND INNER PARTS OF THE HEATER-COOLER UNIT WAS PERFORMED. THE INSPECTION OF THE SORIN HEATER-COOLER SYSTEM 3T ((B)(4)) REVEALED RESIDUALS AND BIOFILM IN SEVERAL LOCATIONS INCLUDING THE PUMPS, WATER CIRCUITS, AND THE TUBING, WHICH ALSO SHOWED DISCOLORATION. BASED ON THESE FINDINGS, IT WAS CONCLUDED THAT THIS ISSUE WAS THE RESULT OF THE USER FAILING TO ADHERE TO THE CLEANING AND DISINFECTION INSTRUCTIONS OUTLINED IN THE IFU. THIS UNIT HAS BEEN DISINFECTED AND RETURNED TO SERVICE. AS CORRECTIVE ACTION, FSCA 9611109-06/03/15-002-C WAS RELEASED TO REMIND OUR CUSTOMERS ABOUT THE IMPORTANCE OF ADHERING TO THE WATER MANAGEMENT AND DISINFECTION PROCEDURE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE FACILITY DID NOT PROVIDE THE EVENT DATE. THE INFORMATION WILL BE FORWARDED IF MADE AVAILABLE. BRAND NAME: SORIN HEATER-COOLER SYSTEM 3T; COMMON DEVICE NAME: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS; MODEL NUMBER: 16-02-80; SERIAL NUMBER: (B)(4). THE HEATER/COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO HEATER/COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510K#: K052601) MANUFACTURE DATE: 11/2000. SORIN GROUP (B)(4) MANUFACTURES THE SORIN HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN THE (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE HEATER COOLER MACHINES TESTED POSITIVE FOR MYCOBACTERIA DURING MAINTENANCE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. INITIALLY THE FACILITY DID NOT PROVIDE THE SERIAL NUMBERS FOR THE INVOLVED MACHINES SO ONLY 1 MEDWATCH REPORT WAS FILED. FOLLOW-UP COMMUNICATION HAS REVEALED THAT THE ISSUE INVOLVES 4 SEPARATE MACHINES. THEREFORE 3 ADDITIONAL MEDWATCH REPORTS (MFR REPORT NUMBERS 9611109-2015-00474, 9611109-2015-00475 AND 9611109-2015-00476) HAVE BEEN FILED TO CAPTURE THE OTHER MACHINES. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN HEATER-COOLER SYSTEM 3T MACHINE TESTED POSITIVE FOR BACTERIA DURING MAINTENANCE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. ON JANUARY 13TH, 2016, A RETROSPECTIVE EVALUATION IDENTIFIED THAT THIS ADDITIONAL INFORMATION HAS NOT YET BEEN PROVIDED IN A MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS MEANT TO RETRACT A PRIOR REPORT (FOLLOW-UP #4) THAT WAS SUBMITTED ON JANUARY 27, 2016. WE ARE RETRACTING FOLLOW-UP #4 BECASE IT WAS DISCOVERED UPON FURTHER REVIEW THAT THE A DHR REVIEW HAS NOT BEEN COMPLETED FOR THIS NON-US DEVICE.

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS NOT PROVIDED THE HEATER COOLER MODEL NUMBER. THE BRAND NAME AND COMMON NAME IS UNKNOWN. THE INFORMATION WILL BE FORWARD IF MADE AVAILABLE. THE FACILITY HAS NOT PROVIDED THE HEATER COOLER SN. THE MANUFACTURING DATE WILL BE FORWARDED IF MADE AVAILABLE. SORIN GROUP (B)(4) MANUFACTURES THE HEATER-COOLER. THE INCIDENT OCCURRED IN THE (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE HEATER COOLER MACHINES TESTED POSITIVE FOR MICRO BACTERIA DURING MAINTENANCE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. THE FACILITY HAS NOT PROVIDED THE MODEL NUMBER. THE 510(K) NUMBER WILL BE FORWARDED IF MADE AVAILABLE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE HEATER COOLER MACHINES TESTED POSITIVE FOR MICRO BACTERIA DURING MAINTENANCE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420677 UNKNOWN UNKNOWN DWC SORIN GROUP DEUTSCHLAND UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP