BEUDAMED
    FDA Adverse Event Summary report: N

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    MDR report key: 6002750 · Received October 6, 2016

    Report

    Report Number
    9680841-2016-00504
    Date Received
    October 6, 2016
    Date of Event
    July 28, 2016
    Report Date
    September 7, 2016
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER WAS NOT PROVIDED. THE COMPLAINED INSPIRE 8 START OXYGENATOR (CATALOG NUMBER 50710, LOT 1510300001), IS A NON-STERILE UNIT THAT WAS ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE LOT NUMBER OF THE CONVENIENCE PACK WAS NOT PROVIDED, SO THE EXPIRATION DATE IS UNKNOWN. AS THE PRODUCT ITEM 050710 IS NOT DISTRIBUTED IN THE USA, THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050710 IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE PRODUCT ITEM 050710 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130433). DATE OF MANUFACTURE PROVIDED REFERS TO THE MANUFACTURE DATE OF THE NON-STERILE DEVICE. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8 START HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. 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 TUBING CONNECTED TO THE INLET OF THE INSPIRE 8 START OXYGENATOR DISCONNECTED DURING A PROCEDURE. THE OXYGENATOR AND THE HEART-LUNG MACHINE WERE CHANGED-OUT TO COMPLETE THE PROCEDURE. THE CHANGE-OUT TOOK 12 MINUTES AND THE PATIENT BLOOD LOSS WAS 3 LITERS. BLOOD PRODUCTS WERE ADMINISTERED TO THE PATIENT. AT THE DATE OF THIS REPORT, THE PATIENT IS REPORTED TO BE RECOVERING WITH NO ADVERSE EFFECTS. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER IDENTIFIED THAT THE INLET TUBING OF THE OXYGENATOR WAS NOT SECURED WITH A TIE. THIS IS CONTRAINDICATED IN THE DEVICE INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS STILL ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE DISCARDED BY CUSTOMER AFTER USE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8 START HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE COMPLAINED OXYGENATOR AND THE CIRCUIT INTO WHICH THE OXYGENATOR WAS ASSEMBLED WERE DISPOSED OF BY THE CUSTOMER. A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED BY SORIN GROUP (B)(4). THE CUSTOMER REPORTED THAT THE OXYGENATOR TRANS-MEMBRANE PRESSURE INCREASED BEFORE THE DISCONNECTION. THE PUMP SHEET OF THE EVENT WAS NOT MADE AVAILABLE AND THE CLAIMED PRESSURE INCREASE COULD NOT BE VERIFIED. THE INLET TUBING THAT DISCONNECTED FROM THE INLET OXYGENATOR WAS NOT MANUFACTURED BY SORIN GROUP (B)(4), AND IT WAS ALSO NOT MADE AVAILABLE FOR INVESTIGATION. THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, SORIN GROUP (B)(4) LEARNED THAT THE INLET TUBING OF THE OXYGENATOR WAS NOT SECURED WITH A TIE. THIS IS CONTRAINDICATED IN THE DEVICE INSTRUCTIONS FOR USE (IFU). WITHOUT THE ABILITY TO PERFORM A PHYSICAL INVESTIGATION OF THE COMPLAINED DEVICE, A ROOT CAUSE COULD NOT BE DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED. THE DHR VERIFICATION DID NOT REVEAL ANY RELEVANT INFORMATION THAT COULD BE POTENTIALLY LINKED TO THE CLAIMED DEFECT. AVAILABLE INFORMATION DOES NOT ALLOW A CLEAR ASSESSMENT OF THE ORIGIN OF THE DISCONNECTION AND WHETHER IT IS ASCRIBABLE TO A MALFUNCTION OF THE OXYGENATOR. NO FURTHER INVESTIGATION IS POSSIBLE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE. DEVICE DISPOSED OF BY THE CUSTOMER.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TUBING CONNECTED TO THE INLET OF THE INSPIRE 8 START OXYGENATOR DISCONNECTED DURING A PROCEDURE. THE OXYGENATOR AND THE HEART-LUNG MACHINE WERE CHANGED-OUT TO COMPLETE THE PROCEDURE. THE CHANGE-OUT TOOK 12 MINUTES AND THE PATIENT BLOOD LOSS WAS 3 LITERS. BLOOD PRODUCTS WERE ADMINISTERED TO THE PATIENT. AT THE DATE OF THIS REPORT, THE PATIENT IS REPORTED TO BE RECOVERING WITH NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653439 INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 1510300001

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR