BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500

    MDR report key: 4942906 · Received July 27, 2015

    Report

    Report Number
    1217157-2015-00107
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 29, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KHP
    PMA / PMN Number
    K113216
    Removal / Correction Number
    1217157-07-24-2015-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS ISSUED AN URGENT FIELD SAFETY NOTICE (UFSN) 33114 REV. A IN JULY 2014 TO NOTIFY ALL AFFECTED SIEMENS CUSTOMERS ABOUT THE ISSUE. THE SECTION 'ACTIONS TO BE TAKEN BY THE CUSTOMER' OF UFSN WILL INFORM CUSTOMERS TO DISABLE ONE PORT (EITHER THE ETHERNET PORT OR THE SERIAL PORT) ON THE RAPIDPOINT 500 ANALYZER. THE RESOLUTION OF THIS ISSUE WILL BE IMPLEMENTED IN THE NEXT SOFTWARE RELEASE FOR THE RAPID-POINT 500 SYSTEM.

    Additional Manufacturer Narrative · 1

    AFTER SEVERAL EMAIL EXCHANGES WITH CUSTOMER, SIEMENS CONFIRMED THAT THE SERIAL PORT IS CONNECTED TO THE LIS AND IS THE SECONDARY PORT WHILE THE NETWORK PORT IS CONNECTED TO RAPIDCOMM AND IS THE PRIMARY PORT. THE ACTUAL CONNECTION TO THE LIS SYSTEM GOES THROUGH A DEVICE CALLED A 401P WHICH SPLITS THE LIS-3 SIGNAL AND SENDS A REFORMATTED LIS-2 MESSAGE TO THE LIS AND AN LIS-3 MESSAGE TO A TICKET PRINTER WHICH IS USED BY THEM TO OUTPUT SAMPLE RESULTS. THE CORRUPTED MESSAGE IS FROM THE RECEIVED LOGGING ON THE LIS SYSTEM. SINCE SOFTWARE V2.2, THE RP500 HAS DUAL PORT LIS TRANSMISSION CAPABILITY MEANING THE SYSTEM CAN BE CONNECTED TO 2 DATA MANAGEMENT SYSTEMS SUCH AS RAPIDCOMM AND ANOTHER DATA MANAGEMENT SYSTEM(DMS). THIS ALLOWS THE SYSTEM TO COMMUNICATE SIMULTANEOUSLY OVER THE SERIAL AND ETHERNET PORTS AND CONFIGURE EACH PORT TO SEND PATIENT, CALIBRATION, OR QC DATA. USER CAN SELECT WHICH DATA IS SENT OVER WHICH PORT AND CAN SPECIFY WHICH PORT SERVES AS THE PRIMARY INTERFACE. TYPICALLY A USER WOULD SETUP ONE PORT AS THE PRIMARY PORT WHICH WOULD INTERFACE WITH RCOMM OR A LIS AND SEND OUT ALL THE NECESSARY DATA. THEY WOULD THEN USE THE OTHER PORT TO JUST SEND OUT RESULTS, NOT HAVE IT SETUP TO ANY TYPE OF LIS. IN THIS COMPLAINT, THE CUSTOMER IS USING THIS DUAL TRANSMISSION FEATURE BUT BECAUSE THEY SETUP BOTH PORTS TO SEND OUT THE SAME TYPE OF INFORMATION, THE DATA IS GETTING DUPLICATED OR MISSED. SIEMENS INVESTIGATED THE ISSUE AND HAS IDENTIFIED THE ROOT CAUSE; MITIGATIONS WILL BE IMPLEMENTED IN NEW SOFTWARE VERSION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PCO2 RESULT WAS NOT SENT TO LIS (DATA MANAGEMENT SYSTEM). CUSTOMER INDICATED THAT SYSTEM TRANSFERRED HCT RESULT TWICE AND DID NOT SEND PCO2 RESULT IN ONE PATIENT REPORT TO LIS. CUSTOMER ALSO INDICATED THAT THIS ISSUE OCCURRED ONLY ONE TIME SO FAR. THERE WAS NO REPORT OF SERIOUS INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487806 RAPIDPOINT 500 RP 500 KHP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1