BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F HOLLOW FIBER OXY W/ INTEGRATED ART. FILTER AND HARDSHELL VEN/CARD RES

    MDR report key: 7454954 · Received April 24, 2018

    Report

    Report Number
    9680841-2018-00009
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    February 22, 2018
    Report Date
    June 29, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    UDI-DI
    08033178112383
    PMA / PMN Number
    K130433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER WAS NOT PROVIDED. THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. PER EXEMPTION NUMBER E2016005.SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8F HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). (B)(4). 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. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8F HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN KARACHI, PAKISTAN. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). IN THE INITIAL REPORT, IT WAS INCORRECTLY STATED THAT THE INVOLVED DEVICE HAD BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. THE EVENT OCCURRED ON (B)(6) 2018. THE CUSTOMER NOTIFIED SORIN GROUP ITALIA ONLY TWO MONTHS LATER. BASED ON PREVIOUSLY INVESTIGATE SIMILAR CASES, SORIN GROUP ITALIA HAD DETERMINED THAT AFTER A CERTAIN LENGTH OF TIME HAS ELAPSED BETWEEN THE EVENT DATE AND THE INVESTIGATION DATE, THE PHYSICAL INVESTIGATION OF THE DEVICE IS NOT CAPABLE OF YIELDING MEANINGFUL RESULTS. THEREFORE, THE UNIT HAS NOT BEEN REQUESTED FOR RETURN. THE PUMP SHEET FOR THE EVENT HAS NOT BEEN PROVIDED. A REVIEW OF THE DHR OF THE OXYGENATOR LOT CONFIRMED THAT THE DEVICE WAS RELEASED IN COMPLIANCE WITH MANUFACTURER SPECIFICATIONS. BASED ON EVIDENCE FROM PREVIOUSLY INVESTIGATED CASES, SORIN GROUP ITALIA BELIEVES THE MOST LIKELY ROOT CAUSE OF THE REPORTED INCREASED PRESSURE ISSUE TO BE PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THE MOST PROBABLE CAUSE FOR THE PLATELET ADHESION AND FIBRIN DEPOSITION IS MULTI-FACTORIAL AND INCLUDES THE CLINICAL PROCEDURE (E.G SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. THE FAILURE APPEARS TO NOT BE DEVICE-SPECIFIC. TOO MUCH TIME ELAPSED FROM EVENT DATE.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE PRE-MEMBRANE PRESSURE OF AN INSPIRE 8F HOLLOW FIBER OXYGENATOR AND THE TENSION OF THE TUBING BETWEEN THE PUMP OUTLET AND THE OXYGENATOR INLET INCREASED DURING A PROCEDURE. THE REPORT ALSO INDICATED THAT THE PUMP FLOW COULD NOT BE SET HIGHER THAN 2 LPM. THE MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR, WHICH TOOK ROUGHLY 200 SECONDS. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297526 INSPIRE 8F HOLLOW FIBER OXY W/ INTEGRATED ART. FILTER AND HARDSHELL VEN/CARD RES HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL VEN/CARD RESERVOIR DTZ SORIN GROUP ITALIA S.R.L. 8F PH.I.S.I.O. 1706080232 08033178112383

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR