BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCP00706035#ROTAFLOW ENGLISH/US US-PLUG

    MDR report key: 4820870 · Received June 3, 2015

    Report

    Report Number
    8010762-2015-00678
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 5, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEVICE WILL BE INVESTIGATED BY A MAQUET SERVICE TECHNICIAN. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED JUNE 2, 2015, REGARDING THE INITIAL REPORTED INCIDENT WHICH WHEN RE-EVALUATED, DETERMINED THAT THE INITIALLY REPORTABLE ISSUE IS NOW DEEMED NOT REPORTABLE. UNFORTUNATELY, THE INITIAL REPORTED ISSUE WAS NOT RE-ASSESSED AND THUS NO UPDATE WAS PROVIDED AT THAT TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: "THE ONLY PROBLEM WAS THAT THE ERROR MESSAGE WAS DISPLAYED, BUT THE PUMP DID NOT STOP, AND ALSO, ASIDE FROM THE MESSAGE, IT CONTINUED TO FUNCTION CORRECTLY. THEY DID NOT NEED TO INTERVENE, OR SWITCH THE PUMP TO CONTINUE THERAPY, AND WERE ABLE TO CONTINUE THEIR CASE. THERE WAS NO DELAY IN THERAPY, AND THERE WAS NO NEGATIVE EFFECT ON THE PATIENT. AFTER THE CASE, THEY PULLED THE UNIT OUT OF SERVICE AND PLACED A SERVICE CALL." BASED ON THE ADDITIONAL INFORMATION, IT IS EVIDENT THAT THE INITIAL REPORTED ISSUE WAS MADE REPORTABLE IN ERROR DUE TO NOT SUFFICIENT INFORMATION BEING AVAILABLE. THIS FOLLOW-UP REPORT SERVES AS A CORRECTION TO CHANGE THE REPORTABLE STATUS, OF THIS COMPLAINT, TO NOT REPORTABLE BASED ON THE ADDITIONAL INFORMATION RECEIVED. THIS FOLLOW-UP REPORT WILL ALSO SERVE AS A FINAL REPORT REGARDING THIS ISSUE. NO FURTHER UPDATE WILL BE PROVIDED.

    Description of Event or Problem · 1

    (B)(4). THE INITIAL MEDWTCH REPORT FOR THIS COMPLAINT WAS SUBMITTED ON PAPER UNDER MFR REPORT # 8010762-2015-00678.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTA FLOW PUMP READING ART/STOP OCCURRED WHEN CARDIOPLEGIA PUMP WAS RUNNING. THE PUMP DID NOT STOP AND CONTINUED TO FUNCTION CORRECTLY. NO REPORTED PT EFFECT. UPON COMPLETION OF THE CASE THE DEVICE WAS REMOVED FROM SERVICE. (B)(4). (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357271 MCP00706035#ROTAFLOW ENGLISH/US US-PLUG CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1