BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE SIEMENS 10P

    MDR report key: 10280012 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00169
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    March 12, 2020
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    PMA / PMN Number
    K945585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D10, G4, G7, H2, H3, H4, H6, H10 DEVICE IDENTIFIER # (B)(4). CABLE WAS RETURNED FOR EVALUATION. DHR - THE REVIEW REVEALED NO ANOMALIES FAILURE ANALYSIS WAS COMPLETED, AND THE UNIT PASSED ALL FUNCTIONAL TESTING. THE ROOT CAUSE COULD THEREFORE NOT BE DETERMINED. THE AS FOUND CONDITION DID REVEAL SOME KINKING AND DAMAGED THREADS. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4) OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 1226348-2020-00168. 1226348-2020-00170. A FACILITY REPORTED AN ICP CABLE MALFUNCTION. A CERELINK SENSOR WAS IMPLANTED. SHORTLY THEREAFTER, THE ICP EXPRESS MONITOR SHOWED -99MMHG. THE CUSTOMER THINKS IT WAS THE CERELINK SENSOR BUT IT COULD ALSO BE THE CONNECTING CABLE OR THE MONITOR. WHEN THE SALES REP RECEIVED THESE ITEMS, SHE WAS ALSO GIVEN 3 SIEMENS INTERFACE CABLES. THIS COMPLAINT IS REGISTERING THE SECOND OF THESE THREE CABLES. MONITORING WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739310 CABLE SIEMENS 10P ICP EXPRESS - CABLES GWM INTEGRA LIFESCIENCES MANSFIELD Y7487

    Patients

    Seq Age Sex Outcome Treatment
    1