BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA

    MDR report key: 11067525 · Received December 23, 2020

    Report

    Report Number
    2016493-2020-79974
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Report Date
    December 3, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    UDI-DI
    10885403812002
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2720-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR (B)(6) , WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 30SEP2005. 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.

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN NOTED THAT THEY: REPLACED LINEAR SENSOR, FRONT COVER, REAR CASE, LEFT/RIGHT HANDLE, FRONT DOOR, BARREL CLAMP, MODULE KEY LOCK LABEL, LEFT/RIGHT IUI, INTERNAL FRAME, FLANGE RETAINER, AND WIPER SEAL. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 09/30/2005. 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. BASED ON THE FINDINGS, SERVICE DETERMINED THAT THE PROXIMATE CAUSE OF THE REPORTED ISSUE WAS DUE TO ELECTRICAL FAILURE OF THE LINEAR POTENTIOMETER. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR (B)(6) , WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. THERE ARE CAPA #'S NOTED FOR THE FOLLOWING PARTS REPLACED THAT HAVE AN ALREADY EXISTING CAPA. CAPA # CA-2018-0161 FOR IUI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALARM - ERROR CODES / MESSAGES/351.6660. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALARM - ERROR CODES / MESSAGES/351.6660. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICES HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALARM - ERROR CODES / MESSAGES/351.6660. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529274 ALARIS PCA PUMP, INFUSION MEA CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1