BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONTROL PANEL MRP 85

    MDR report key: 4922700 · Received July 13, 2015

    Report

    Report Number
    9611109-2015-00236
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 9, 2015
    Report Date
    February 6, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K062396
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 CONTROL PANEL MRP 85. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE KNOB ON THE CONTROL PANEL BECAME LOOSE DURING A PROCEDURE. THE CLINICIAN HAD DIFFICULTY INCREASING THE FLOW RATE BUT WAS ABLE TO COMPLETE THE CASE WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 CONTROL PANEL MRP 85. THE INCIDENT OCCURRED IN (B)(6). (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED ISSUE. THROUGH TROUBLESHOOTING, THE SERVICE REPRESENTATIVE WAS ABLE TO TRACE THE FAILURE TO A DEFECTIVE ENCODER. THE ENCODER WAS REPLACED AND SUBSEQUENT TESTING DID NOT IDENTIFY FURTHER FAILURES. THE UNIT WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE KNOB ON THE CONTROL PANEL BECAME LOOSE DURING A PROCEDURE. THE CLINICIAN HAD DIFFICULTY INCREASING THE FLOW RATE BUT WAS ABLE TO COMPLETE THE CASE WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454395 S5 CONTROL PANEL MRP 85 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND GMBH 28-95-85 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP