BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8120 ALARIS PCA

    MDR report key: 10769685 · Received November 2, 2020

    Report

    Report Number
    2016493-2020-29664
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Report Date
    March 20, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    FAILED FORCE ACCURACY. FORCE SENSOR ASSEMBLY- FAILED CALIBRATION. CASE FRONT- CRACKED. CASE REAR- CRACKED. IUI- DAMAGE. CARRIAGE ASSEMBLY- TUBE DRIVE BENT. BARREL CLAMP ASSEMBLY- CRACKED. PCA DOOR- HINGE DAMAGED. MODULE LATCH- CRACKED. LABEL- DAMAGED. CARRIAGE ASSEMBLY- SPLIT NUT DAMAGED/WORN. INTERNAL FRAME- CRACKED. PLUNGER DETECT SENSOR- FAILURE. FLANGE GRIPPER- CRACKED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. 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. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN 9951803 WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236166 8120 ALARIS PCA PUMP, INFUSION FRN CAREFUSION SD 8120

    Patients

    Seq Age Sex Outcome Treatment
    1