BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMS VUE PUMP

    MDR report key: 10521464 · Received September 11, 2020

    Report

    Report Number
    1221934-2020-02547
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Report Date
    August 27, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705020591
    PMA / PMN Number
    K130169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE CENTER. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE DEVICE FROM THE CUSTOMER, HOWEVER, DEFECTS WERE FOUND WITH THE DEVICE DURING SERVICE EVALUATION. IT WAS FOUND THAT THE RIGHT BEZEL INSERT AND PINCH VALVE GUARD WERE BROKEN. FURTHER, DOOR MOUNTING POST WAS REPLACED TO ADDRESS THE ISSUE OF THE LOCKING UP OF THE IRRIGATION PRESSURE ARM ASSEMBLY. ALSO REPLACED WORN FINGERS ON PRESSURE ARM HOUSING (PREVENTIVE MAINTENANCE) WITH TIP REPLACEMENT KIT. PER SB, PERFORMED SOFTWARE UPGRADE TO 3.11 TO ADDRESS THE ISSUE OF THE PUMP NOT RECOGNIZING THE ACCESSORY DEVICES AND THE LOWER BEZEL ASSEMBLY WAS REPLACED AS PER NCR#20-00007. THE DEVICE WAS TESTED AND FOUND TO BE WORKING ACCORDING TO SPECIFICATIONS. USER MISHANDLING OF THE DEVICE OR A PROBABLE FALL IS THE MOST LIKELY CAUSE OF THE PHYSICAL DAMAGE TO THE COMPONENTS OF THE PUMP. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (SERIAL NUMBER : (B)(6)), AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR, IT WAS DETERMINED THAT THE PUMP DEVICE HAD BROKEN RIGHT BEZEL INSERT AND PINCH VALVE GUARD. IT WAS FURTHER REPORTED THAT THE IRRIGATION PRESSURE ARM ASSEMBLY WAS LOCKING UP. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989928 FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC HRX DEPUY MITEK LLC US 284002 10886705020591

    Patients

    Seq Age Sex Outcome Treatment
    1