BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6M HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER HARDSHELL VEN/CARD RES

    MDR report key: 6004154 · Received October 6, 2016

    Report

    Report Number
    9680841-2016-00506
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    October 27, 2015
    Report Date
    December 11, 2015
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE INSPIRE 6 M OXYGENATOR, LOT NUMBER 1505180122, IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO A CONVENIENCE PACK (CATALOG 044028600, LOT 1522400081) AND STERILIZED BEFORE DISTRIBUTION AND USE IN THE USA. EXPIRATION DATE (MM/DD/YYY) OF CONVENIENCE PACK: 08/31/3017. (B)(4). DEVICE MANUFACTURE DATE (MM/DD/YYY) FOR CONVENIENCE PACK: 08/12/2015. THE INSPIRE 6 M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER HARDSHELL VENOUS/CARDIOTOMY RESERVOIR WAS ASSEMBLED INTO A CONVENIENCE PACK FOR STERILIZATION AND DISTRIBUTION IN THE USA. THE DEVICE IS ALSO DISTRIBUTED IN THE USA AS A STERILE DEVICE (510(K) NUMBER: K130433). SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6 HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT FLUID WAS NOTED COMING OUT OF ONE OF THE WATER INLET/OUTLET PORTS OF THE INSPIRE 6 M OXYGENATOR DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. LEAK TESTING OF THE RETURNED UNIT CONFIRMED THE PRESENCE OF A LEAK FROM THE HEAT EXCHANGER FIBER BUNDLE. INSPECTION OF THE BUNDLE UNDER MAGNIFICATION FOUND THAT THE LEAK WAS CAUSED BY DAMAGE TO ONE OF THE FIBERS. INITIALLY, THIS COMPLAINT WAS EVALUATED AS NOT REPORTABLE. HOWEVER, THE DAMAGE TO THE HEAT EXCHANGER IDENTIFIED DURING EVALUATION MAKES THE EVENT REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THIS TYPE OF ISSUE FOUND THAT A MEDWATCH REPORT HAS NOT YET BEEN SUBMITTED FOR THIS EVENT. ALL UNITS ARE 100% LEAK TESTED DURING THE MANUFACTURING PROCESS. SORIN GROUP (B)(4) HAS CONCLUDED THAT THE ISSUE WAS LIKELY RELATED TO AN ISOLATED DEFECT IN THE FIBER WHICH WAS NOT APPARENT DURING IN PROCESS TESTING. THIS DEFECT HAS BEEN CLASSIFIED AS A RARE EVENT AND NO TREND FOR THIS TYPE OF ISSUE HAS BEEN IDENTIFIED. SORIN GROUP (B)(4) HAS INITIATED A CAPA FOR THIS TYPE OF ISSUE AND CORRECTIVE ACTIONS WERE IMPLEMENTED IN 2016 WITH THE AIM OF IMPROVING THE QUALITY OF THE FIBERS AND IMPROVING THE EFFECTIVENESS OF IN-PROCESS TESTING. THE COMPLAINED OXYGENATOR WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THIS CORRECTIVE ACTION. SORIN GROUP (B)(4) HAS NOT RECEIVED ANY REPORTS OF SIMILAR EVENTS INVOLVING UNITS MANUFACTURED AFTER THE IMPLEMENTATION OF THE CORRECTIVE ACTIONS. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT FLUID WAS NOTED COMING OUT OF ONE OF THE WATER INLET/OUTLET PORTS OF THE INSPIRE 6 M OXYGENATOR DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657294 INSPIRE 6M HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER HARDSHELL VEN/CARD RES OXYGENATOR, CARDIOPULMONARY BYPASS, DTZ SORIN GROUP ITALIA SRL 1505180122

    Patients

    Seq Age Sex Outcome Treatment
    1