BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 6000932 · Received October 5, 2016

    Report

    Report Number
    9680841-2016-00501
    Date Received
    October 5, 2016
    Date of Event
    August 13, 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). INITIAL CONTACT TELEPHONE NUMBER: (B)(6). PMA 510(K): 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 RECEIVED A REPORT THAT THE TUBING CONNECTED TO THE INLET OF THE INSPIRE 8 START OXYGENATOR DISCONNECTED DURING CARDIOPULMONARY BYPASS. THE CUSTOMER REPORTED THAT THE PRE-MEMBRANE PRESSURE WAS ABOVE 400 MMHG AT 32 DEGREES C. BLOOD LOSS WAS ROUGHLY 400CC AND BLOOD PRODUCT WAS ADMINISTERED TO THE PATIENT. THE DISCONNECTED TUBE WAS REPLACED WITH A NEW CONNECTION AND THE BLOOD FLOW WAS DECREASED TO 75% TO COMPLETE THE PROCEDURE. 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 INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE NOT YET RETURNED TO MANUFACTURER.

    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 DEVICE WAS REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATE. HOWEVER, NEITHER THE COMPLAINED OXYGENATOR NOR PHOTOGRAPHIC EVIDENCE OF THE EVENT WAS PROVIDED. ATTEMPTS TO BETTER CLARIFY THE DETAILS OF THE EVENT AND TO RETRIEVE A READOUT OF THE PUMP WERE ALSO NOT SUCCESSFUL. A DHR VERIFICATION DID NOT REVEAL ANY RELEVANT INFORMATION POTENTIALLY LINKED WITH THE CLAIMED ISSUE. AS AN INVESTIGATION COULD NOT BE PERFORMED, A ROOT CAUSE WAS NOT IDENTIFIED AND CORRECTIVE ACTIONS WERE NOT DETERMINED. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR THIS TYPE OF ISSUE. DEVICE NOT RETURNED TO MANUFACTURER.

    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 CARDIOPULMONARY BYPASS. THE CUSTOMER REPORTED THAT THE PRE-MEMBRANE PRESSURE WAS ABOVE 400 MMHG AT 32 DEGREES C. BLOOD LOSS WAS ROUGHLY 400CC AND BLOOD PRODUCT WAS ADMINISTERED TO THE PATIENT. THE DISCONNECTED TUBE WAS REPLACED WITH A NEW CONNECTION AND THE BLOOD FLOW WAS DECREASED TO 75% TO COMPLETE THE PROCEDURE. 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
    653316 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 65 YR