BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6041286 · Received October 19, 2016

    Report

    Report Number
    3007566237-2016-03627
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 15, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (B)(4) FOUND NO ANOMALIES. ANALYSIS OF THE CATHETER (B)(4) FOUND THAT THE PIN CONNECTOR/COLLET WAS NOT FULLY LOCKED INTO PLACE. THE CONCLUSION CODE 92 APPLIES TO THE 8784 CATHETER (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE WAS CORRECTED FROM LLK TO LKK. COMMON DEVICE NAME WAS ALSO CORRECTED FROM LEGGING, COMPRESSION, NON-INFLATABLE TO PUMP, INFUSION, IMPLANTED, PROGRAMMABLE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED ON (B)(6) 2016 THAT A CATHETER WAS REVISED WITH A CATHETER PUMP SEGMENT REVISION KIT BUT THE CONNECTOR PIECE OF THE FIRST KIT UTILIZED WAS BROKEN UPON OPENING THE KIT. ANOTHER KIT WAS UTILIZED AND THE EXISTING CATHETER WAS REVISED. IT WAS NOTED THAT THE BROKEN CONNECTOR PIECE WAS ACCIDENTALLY THROWN OUT AND WOULD NOT BE RETURNED TO THE MANUFACTURER. REFER TO MANUFACTURER REPORT 3004209178-2016-22048 FOR EVENT PERTAINING TO THE CATHETER REVISION. NO SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PERTAINING TO THIS EVENT PREVIOUSLY REPORTED IN MFR. REPORT #3004209178-2016-22048.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 2016-OCT-17. IT WAS REPORTED THAT THE CAUSE OF THE BROKEN CONNECTOR PIECE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693286 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention