BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSYTEM III INFUSION PUMP

    MDR report key: 12201576 · Received July 21, 2021

    Report

    Report Number
    2016493-2021-509709
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Report Date
    June 26, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403928659
    PMA / PMN Number
    K933545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. . THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 25MAR2011. 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 SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN BD2 TRACKWISE WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE.

    Description of Event or Problem · 0

    PROBLEM DESCRIPTION (B)(6) 2018 08:51:00 (B)(6). PLEASE REFER TO FILE #2018-023278-251312 FROM CAD. PROBLEM DESCRIPTION (B)(6) 2018 11:33:56 (B)(6). NPI SN (B)(6) HAD A MSIII INFUSION PUMP CHANNEL A FAILED PRESSURE CALIBRATION 12 PSI VERIFICATION. I REVIEWED THE CALIBRATION DATA WITH HIM AND ADVISED HIM TO REPLACE PRESSURE SENSOR.

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF (B)(6) 2011. 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 SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(4) WAS PERFORMED IN TRACKWISE WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. CAPA REFERENCE: N/A. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    (B)(4). NPI SN (B)(4). (B)(6) HAD A MSIII INFUSION PUMP CHANNEL A FAILED PRESSURE CALIBRATION 12 PSI VERIFICATION. I REVIEWED THE CALIBRATION DATA WITH HIM AND ADVISED HIM TO REPLACE PRESSURE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102012 MEDSYTEM III INFUSION PUMP PUMP, INFUSION FRN CAREFUSION SD 2865 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown