BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP.

    MDR report key: 5213708 · Received November 10, 2015

    Report

    Report Number
    9617494-2015-00027
    Event Type
    Injury
    Date Received
    November 10, 2015
    Report Date
    October 16, 2015
    Manufacturer
    GMS-GESELLSCHAFT FUR MEDIZINISHE
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THIS IS TO CLARIFY THAT THIS COMPLAINT IS IN REGARDS TO THE 1ST CATHETER - NO SERIAL AND LOT NUMBER REPORTED (PREVIOUSLY REPORTED IN THE INITIAL MDR AS THE SECOND CATHETER WITH SERIAL NUMBER (B)(4) LOT NUMBER: 240715. LINKED TO MFG REPORT NUMBER: 9617494-2015-00026. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 01/19/2016. PRODUCT WAS NOT RETURNED FOR EVALUATION. DHR REVIEW NOT POSSIBLE SINCE BATCH INFORMATION WAS NOT PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED SINCE NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS. THIS IS IN REGARDS TO THE SECOND CATHETER. IT WAS REPORTED THAT NEUROSURGERY FELT THAT THEY HAD TWO DEFECTIVE LICOX CATHETERS NOT CAUSED BY INSERTION. THEY WERE UNDER-READING THE BRAIN TEMPERATURE BUT GIVING AN "OKAY" PBTO2 (BRAIN TISSUE PARTIAL OXYGEN TENSION). THE RESIDENT STATED THE SECOND CATHETER HE SAVED LOOKED DEFECTIVE BUT IT LOOKED ALRIGHT TO THE (B)(6). THE STAFF NURSE REPORTED TO THE (B)(6) THAT THE TEMPERATURE ALARM KEPT ALARMING AND SHE COULDN'T SHUT IT OFF. THE CLINICAL NURSE SPECIALIST EXPLAINED TO THE NURSE THAT SHE COULDN'T SHUT IT OFF FOR A REASON. THE PBTO2 DEPENDS ON THE BRAIN TEMPERATURE TO DETERMINE A CORRECT PBTO2 AND NOBODY'S BRAIN TEMPERATURE SHOULD BE 22. THE STAFF NURSE STATED THE SMART CARD MATCHED THE NUMBERS ON THE CATHETER EACH TIME. WHEN THE TEMPERATURE ALARM WAS SOUNDING (READING 22 DEGREES CELSIUS), THE PBTO2 WAS 20 MMHG OR GREATER. WITH THE THIRD CATHETER, THE PBTO2 WAS LESS THAN 15 BUT THE BRAIN TEMPERATURE APPROXIMATED THE BODY TEMPERATURE. THEY WENT THROUGH 3 CATHETERS AND THE 3RD ONE SEEMED TO WORK. THE THIRD CATHETER WAS DISCONTINUED LESS THAN 24 HOURS LATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND ON (B)(6) 2015, THE FOLLOWING WAS RECEIVED FROM THE CUSTOMER: NO OBVIOUS HARM WAS CAUSED TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745348 PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP. LICOX BOLTS CATHETERS & KITS GWM GMS-GESELLSCHAFT FUR MEDIZINISHE 240715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention