BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11839785 · Received May 18, 2021

    Report

    Report Number
    2016493-2021-506158
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    November 16, 2020
    Report Date
    November 19, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT ADMINISTRATION SET WAS NOT RETURNED AND COULD NOT BE INSPECTED. LVP SN (B)(4) (CHANNEL B) THE DEVICE WAS RECEIVED IN FAIR CONDITION. THE INSTRUMENT SEAL WAS INTACT. HOWEVER, MULTIPLE VOID MARKS WERE VISIBLE WHICH IS INDICATIVE OF PREVIOUS REMOVAL. DRIED FLUID AND CORROSION WERE OBSERVED ON THE MALE IUI. DRIED FLUID WAS OBSERVED ON THE FEMALE IUI. PLATEN ASSEMBLY, POST, HINGE, PINS, SPRINGS, AND BUTTONS ARE ALL INTACT AND DID NOT INTERFERE WITH THE DOOR OPERATION. LATCH SEAR ARE INSTALLED PROPERLY AND DID NOT INTERFERE WITH THE DOOR OPERATION. ALL PARTS ARE MANUFACTURED BY BD. BEZEL WAS OBSERVED IN GOOD CONDITION (DATE CODE: JUNE 2019). LOG ANALYSIS RESULTS: THE CUSTOMER REPORTED AN EVENT DATE OF (B)(6) 2020. REVIEW OF THE PCU ERROR LOG SHOWED NO ERRORS WERE RECORDED ON THE REPORTED EVENT DATE. REVIEW OF THE PCU EVENT LOG SHOWED, PRIOR TO THE REPORTED EVENT DATE THE PCU WAS POWERED ON AT 2:52 PM ON (B)(6) 2020. LVP SN (B)(4)(CHANNEL B). TIMED RATE ACCURACY TESTING (DIR (B)(4)) WAS PERFORMED USING THE RETURNED ADMINISTRATION SET, SOURCE DEVICE SN (B)(4) AND THE RETURNED PCU SN (B)(4) TO DETERMINE IF THE SYSTEM IS DELIVERING FLUID IN SPECIFICATION. RESULTS INDICATE THAT THE SYSTEM WAS OPERATING WITHIN SPECIFICATION. SEE APPENDIX FOR RESULTS. TEST METHOD INFORMATION: 1503-001-006-R RATE ACCURACY TEST METHOD (DIR (B)(4)) A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 08/07/2012. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SOURCE DEVICE LVP SN (B)(4) WAS PERFORMED 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 RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR THE SOURCE DEVICE LVP SN (B)(4) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT OF AN UNDER INFUSION WAS NOT IDENTIFIED. THE CUSTOMER¿S COMPLAINT OF AN UNDER INFUSION WAS NOT CONFIRMED OR REPRODUCED. REVIEW OF THE PCU ERROR LOG SHOWED NO ERRORS WERE RECORDED ON THE REPORTED EVENT DATE. REVIEW OF THE PCU EVENT LOG SHOWED, ON THE REPORTED EVENT DATE, THE SUSPECT DEVICE SN (B)(4) (CHANNEL A) SUCCESSFULLY COMPLETED MULTIPLE PROGRAMMED INFUSIONS OF HEPARIN 25000 UNIT/250 ML(DRUGID=(B)(6)), ALTHOUGH MULTIPLE ALARMS FOR PATIENT SIDE OCCLUSION WERE RECORDED. REVIEW OF THE PCU EVENT LOG SHOWED, ON THE REPORTED EVENT DATE, THE SUSPECT DEVICE SN (B)(4) (CHANNEL B) COMPLETED AN INFUSION OF IV FLUIDS (DRUGID= (B)(6)) AT A RATE OF 150 ML/HR BEFORE ADDITIONAL VOLUME WAS PROGRAMMED TO INFUSE. THE DEVICE WAS CHANNELED OFF PRIOR TO INFUSION COMPLETION FOR UNKNOWN REASONS. INSPECTION OF THE DEVICES SHOWED NO ANOMALIES. TESTING SHOWED THE DEVICES WERE DELIVERING FLUIDS WITHIN SPECIFICATION. THE EVENT ADMINISTRATION SETS WERE NOT RETURNED FOR INVESTIGATION. THE DEVICES WERE BEING USED FOR TREATMENT PURPOSES.

    Description of Event or Problem · 1

    THERE WAS A REPORT OF AN ALLEGED UNDER INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736437 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 12281113.| PRI TUBING.