BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11591781 · Received March 30, 2021

    Report

    Report Number
    2016493-2021-31318
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Report Date
    February 25, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE THAT THE FLOW OF THE PUMP MODULE IS TOO LOW OR TOO LOW TO CALIBRATE COULD NOT BE CONFIRMED OR REPLICATED DURING THIS INVESTIGATION. LOG REVIEW COULD NOT BE PERFORMED SINCE THERE WERE NO PUMP MODULE ERROR AND EVENT LOGS. TIMED RATE ACCURACY TESTING PERFORMED FOUND THAT THE RETURNED PUMP MODULE DELIVERED FLUIDS WITHIN SPECIFICATIONS. RESULTS FROM ASM RATE ACCURACY TESTING AND CALIBRATION ANALYSIS INDICATE THAT THE PUMP MODULE WAS OPERATING WITHIN SPECIFICATION AND CALIBRATION WAS NOT REQUIRED. INTERNAL INSPECTION FOUND NO IRREGULARITIES. THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THE ROOT CAUSE OF THE REPORTED ISSUE THAT THE FLOW OF THE PUMP MODULE IS TOO LOW OR TOO LOW TO CALIBRATE COULD NOT BE IDENTIFIED IN THIS INVESTIGATION. SAMPLE INSPECTION: THE INSPECTION PROCESS PERFORMED ON THE PUMP MODULE (B)(6) FOUND NO ISSUES RELEVANT TO THE REPORTED INCIDENT. THE CORROSION WITH DRY RESIDUE FOUND ON THE PINS OF THE RIGHT AND LEFT IUI WERE NOT RELEVANT TO THE REPORTED INCIDENT. ALL PARTS INSPECTED WERE OBSERVED TO BE BD. LOG ANALYSIS RESULTS: THERE WERE NO ERROR AND EVENTS LOGS FOR PUMP MODULE 14198573 TO REVIEW. TEST RESULTS: TIMED RATE ACCURACY TESTING PERFORMED FOUND THAT THE RETURNED PUMP MODULE DELIVERED FLUIDS WITHIN SPECIFICATIONS. THE RESULTS OF THE ASM RATE ACCURACY AND CALIBRATION ANALYSIS PERFORMED ON THE RETURNED PUMP MODULE INDICATED THAT THE DEVICE WAS INFUSING WITHIN SPECIFICATION AND CALIBRATION WAS NOT REQUIRED. TEST METHODS: 1503-001-006-R (01) TIMED RATE ACCURACY TEST METHOD (DIR 10000360036). DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 10/18/2014. 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 (B)(6) 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 WAS PERFORMED FOR (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED 90%-95% OF THE BEZELS ARE FAILING FLOW TEST, APPROXIMATELY 8 OUT OF 10. THE FLOW IS TOO LOW. SOME OF THEM ARE TOO LOW TO CALIBRATE, BELOW 10G. HERE WAS NO PATIENT INVOLVEMENT AS THIS WAS FOUND DURING PREVENTATIVE MAINTENANCE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. ALTHOUGH REQUESTED, PATIENT INFORMATION WAS NOT PROVIDED. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED 90%-95% OF THE BEZELS ARE FAILING FLOW TEST, APPROXIMATELY 8 OUT OF 10. THE FLOW IS TOO LOW. SOME OF THEM ARE TOO LOW TO CALIBRATE, BELOW 10G. HERE WAS NO PATIENT INVOLVEMENT AS THIS WAS FOUND DURING PREVENTATIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486409 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 8015| PRI TUBING