BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP.

    MDR report key: 5027830 · Received August 25, 2015

    Report

    Report Number
    9617494-2015-00021
    Event Type
    Injury
    Date Received
    August 25, 2015
    Report Date
    July 30, 2015
    Manufacturer
    GMS
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 10/12/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: THE OPTICAL INSPECTION DOESN¿T SHOW ANY ABNORMALITIES OR DAMAGES APART FROM A BIG AIR BUBBLE OVER 1/3 OF THE TUBING BEGINNING AT THE REAR LUER LOCK. THE CC1P1 MEASURED WITHIN ITS SPECIFICATION. THE DHR OF THE MENTIONED PRODUCT WAS REVIEWED. (LOT: 060215; SN: (B)(4))NO ABNORMALITIES COULD BE DETERMINED. CONCLUSION: ADDITIONAL INFORMATION RECEIVED. ROOT CAUSE HAD TO BE CHANGED. LIKE ALREADY DESCRIBED IN THE INTRODUCTION THE CC1.P1 WAS USED IN COMBINATION WITH AN INCOMPATIBLE BOLT SYSTEM FROM A THIRD-PARTY SUPPLIER (INNERSPACE HUMMINGBIRD). THE COMPLAINT FAILURE FAMILY MUST BE SET TO USER ERROR BECAUSE AN INCOMPATIBLE ACCESSORY (BOLT SYSTEM) WAS USED TO INSERT THE CC1.P1.

    Description of Event or Problem · 1

    THIS IS THE THIRD OF THREE REPORTS (SAME PRODUCT, SIMILAR PROBLEMS, DIFFERENT PATIENTS). THE LEUR LOCK CONNECTION IMMEDIATELY PROXIMAL TO THE WHITE CONNECTION HUB BECAME DISCONNECTED CAUSING THE CATHETER TO LEAK CEREBROSPINAL FLUID (CSF). THE CATHETER HAD TO BE REMOVED FROM PATIENT USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561772 PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP. LICOX BOLTS CATHETERS & KITS GWM GMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other