BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CENTRIFUGAL BLOOD PUMP

    MDR report key: 7706017 · Received July 20, 2018

    Report

    Report Number
    9680841-2018-00022
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    May 22, 2018
    Report Date
    August 23, 2018
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INVOLVEMENT. THE REVOLUTION PHISIO CENTRIFUGAL PUMP IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE REVOLUTION PHISIO CENTRIFUGAL PUMP WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE INVOLVED REVOLUTION PHISIO CENTRIFUGAL PUMP IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050300700) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K030462). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE REVOLUTION CENTRIFUGAL BLOOD PUMP. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE OUTLET PORT OF THE REVOLUTION CENTRIFUGAL BLOOD PUMP WAS FOUND TO BE BROKEN OFF WHEN THE PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURES THE REVOLUTION CENTRIFUGAL BLOOD PUMP. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. (B)(4). THE INVOLVED DEVICE WAS RETURNED TO (B)(4) FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED REVOLUTION PUMP IDENTIFIED THAT THE OUTLET PORT WAS COMPLETELY SEPARATED FROM THE BODY OF THE PUMP. CLOSER INSPECTION OF THE DEVICE REVEALED THAT THE CRACK SURFACES WERE BOTH ROUGH AND JAGGED, INDICATING A STRONG IMPACT STRESS LIKELY DUE TO SHIPPING CONDITIONS. (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549449 REVOLUTION CENTRIFUGAL BLOOD PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA 1801220181

    Patients

    Seq Age Sex Outcome Treatment
    1