BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 12251689 · Received July 30, 2021

    Report

    Report Number
    2016493-2021-511757
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    February 24, 2020
    Report Date
    February 24, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TWO ALARIS SYSTEM PUMP MODULE PRESSURE SENSORS WERE RECEIVED FOR EVALUATION INDIVIDUALLY PACKAGED IN A DISASSEMBLED CONDITION (SEE APPENDIX 1), HOWEVER THEIR LOCATION WITHIN THE PUMP (BOTTLE SIDE / PATIENT SIDE) WAS NOT ANNOTATED. A VISUAL INSPECTION OF THE DISASSEMBLED PARTS IDENTIFIED: SENSOR # 1: PN: XZ208525-FSA MEXICO 094190623.DATE CODE = 04-APR-2019. ALL SECURING TABS PRESENT ON UPPER HOUSING (SEE APPENDIX 2). DAMAGE TO SENSOR OVERLAY (SEE APPENDIX 3). DAMAGE / WITNESS MARKS ON UPPER HOUSING (SEE APPENDIX 4). SENSOR #2: PN: XZ208525-FSA MEXICO 094190819. DATE CODE = 04-APR-2019. ALL SECURING TABS PRESENT ON UPPER HOUSING (SEE APPENDIX 5). BOTH SENSORS WERE REASSEMBLED AND THE UPPER AND LOWER HOUSING LOCKED TOGETHER WITHOUT ANY ISSUES. THE SENSORS WERE ASSEMBLED INTO A TEST PUMP MODULE AND LOCKED / SECURED INTO POSITION BY THE BEZEL ASSEMBLY RELEASE TABS, AND USING THE ALARIS SYSTEM MAINTENANCE (ASM) SOFTWARE THE VOLTAGE RANGE OF EACH SENSOR WERE MEASURED AND IN SPECIFICATION VOLTAGES WERE RECORDED. PRESSURE CALIBRATION AND VERIFICATION WAS PERFORMED AND ALL RESULTS WERE WITHIN SPECIFICATION. AN INFUSION WAS STARTED AND UPSTREAM AND DOWNSTREAM OCCLUSIONS WERE INTRODUCED WITH THE PUMP RESPONDING WITH THE CORRECT ALARM / ERROR MESSAGE. THE TEST PUMP MODULE WAS SUBJECTED TO A CONTINUOUS INFUSION FOR 24 HOURS WHICH WAS COMPLETED FAILURE FREE. THE DEVICE HISTORY RECORD WAS REVIEWED AT THE MANUFACTURING FACILITY AND IT DID NOT SHOW ANY MANUFACTURING ISSUES DURING PRODUCTION BUILD FOR THIS PUMP. A REVIEW OF THE SERVICE DATABASE INDICATED NO SERVICE REPAIR HISTORY SINCE THE RECEIPT OF THE PUMP DURING JUL-2019 THIS INVESTIGATION IS INCONCLUSIVE AS A ROOT CAUSE FOR THE DISASSEMBLED PRESSURE SENSORS COULD NOT BE IDENTIFIED. AS THE PUMP MODULE WAS NOT RETURNED FOR EVALUATION IT IS NOT POSSIBLE TO COMMENT ON THE CONDITION OF THE BEZEL ASSEMBLY RELEASE TABS, THE SECURITY OF THE PRESSURE SENSORS OR IDENTIFY EVIDENCE OF IMPACT DAMAGE. A REVIEW OF THE FEEDBACK DATABASE HAS IDENTIFIED THIS TO BE THE FIRST REPORT FOR THIS ISSUE, HOWEVER BD WILL CONTINUE TO MONITOR ALL FEEDBACK TO ENSURE THAT A TREND IS NOT DEVELOPING. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE.

    Description of Event or Problem · 0

    THE REPORTED FEEDBACK SUGGESTS THAT THE PRESSURE SENSOR IS BROKEN.

    Additional Manufacturer Narrative · 1

    TWO ALARIS SYSTEM PUMP MODULE PRESSURE SENSORS WERE RECEIVED FOR EVALUATION INDIVIDUALLY PACKAGED IN A DISASSEMBLED CONDITION, HOWEVER THEIR LOCATION WITHIN THE PUMP (BOTTLE SIDE / PATIENT SIDE) WAS NOT ANNOTATED. A VISUAL INSPECTION OF THE DISASSEMBLED PARTS IDENTIFIED: SENSOR # 1: PN: XZ208525-FSA (B)(6) .DATE CODE: (B)(6) 2019, ALL SECURING TABS PRESENT ON UPPER HOUSING. DAMAGE TO SENSOR OVERLAY. DAMAGE / WITNESS MARKS ON UPPER HOUSING. SENSOR #2: PN: XZ208525-FSA (B)(6). DATE CODE: (B)(6) 2019. ALL SECURING TABS PRESENT ON UPPER HOUSING. BOTH SENSORS WERE REASSEMBLED AND THE UPPER AND LOWER HOUSING LOCKED TOGETHER WITHOUT ANY ISSUES. THE SENSORS WERE ASSEMBLED INTO A TEST PUMP MODULE AND LOCKED / SECURED INTO POSITION BY THE BEZEL ASSEMBLY RELEASE TABS, AND USING THE ALARIS SYSTEM MAINTENANCE (ASM) SOFTWARE THE VOLTAGE RANGE OF EACH SENSOR WERE MEASURED AND IN SPECIFICATION VOLTAGES WERE RECORDED. PRESSURE CALIBRATION AND VERIFICATION WAS PERFORMED AND ALL RESULTS WERE WITHIN SPECIFICATION. AN INFUSION WAS STARTED AND UPSTREAM AND DOWNSTREAM OCCLUSIONS WERE INTRODUCED WITH THE PUMP RESPONDING WITH THE CORRECT ALARM / ERROR MESSAGE. THE TEST PUMP MODULE WAS SUBJECTED TO A CONTINUOUS INFUSION FOR 24 HOURS WHICH WAS COMPLETED FAILURE FREE. THE DEVICE HISTORY RECORD WAS REVIEWED AT THE MANUFACTURING FACILITY AND IT DID NOT SHOW ANY MANUFACTURING ISSUES DURING PRODUCTION BUILD FOR THIS PUMP. A REVIEW OF THE SERVICE DATABASE INDICATED NO SERVICE REPAIR HISTORY SINCE THE RECEIPT OF THE PUMP DURING JUL-2019. THIS INVESTIGATION IS INCONCLUSIVE AS A ROOT CAUSE FOR THE DISASSEMBLED PRESSURE SENSORS COULD NOT BE IDENTIFIED. AS THE PUMP MODULE WAS NOT RETURNED FOR EVALUATION IT IS NOT POSSIBLE TO COMMENT ON THE CONDITION OF THE BEZEL ASSEMBLY RELEASE TABS, THE SECURITY OF THE PRESSURE SENSORS OR IDENTIFY EVIDENCE OF IMPACT DAMAGE. A REVIEW OF THE FEEDBACK DATABASE HAS IDENTIFIED THIS TO BE THE FIRST REPORT FOR THIS ISSUE, HOWEVER BD WILL CONTINUE TO MONITOR ALL FEEDBACK TO ENSURE THAT A TREND IS NOT DEVELOPING. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE.

    Description of Event or Problem · 1

    THE REPORTED FEEDBACK SUGGESTS THAT THE PRESSURE SENSOR IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150567 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD ALARIS SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown