BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 9775695 · Received March 2, 2020

    Report

    Report Number
    3002809144-2020-00154
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    February 13, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    JJE
    UDI-DI
    00380740137380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE SITE VISIT, THE FIELD SERVICE REPRESENTATIVE REPLACED THE TUBING, PERISTALTIC HEAD (PART NUMBER (PN) 7-202464-01), WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ALINITY C PROCESSING MODULE, SERIAL NUMBER AC01751, SERVICE HISTORY, IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO SUBSEQUENT OCCURRENCES OF DISCREPANT RESULTS DOCUMENTED AFTER THE PART WAS REPLACED BY SERVICE. A 12-MONTH REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE TUBING, PERISTALTIC HEAD. A REVIEW OF THE ALINITY C TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT DESCRIBED IN THIS COMPLAINT. THE ALINITY CI-SERIES OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS, TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM AND TROUBLESHOOTING OF PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC SAMPLE RESULTS. THE ALINITY C SERVICE DOCUMENTATION PROVIDES INSTRUCTION FOR THE REMOVAL AND REPLACEMENT OF THE TUBING, PERISTALTIC HEAD (PN 7-202464-01). BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C PROCESSING MODULE, SERIAL NUMBER AC01751, THE TUBING, PERISTALTIC HEAD (PN 7-202464-01).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DEPRESSED SODIUM (NA) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 (B)(6) ALINITY (B)(6). (NORMAL RANGE 136 TO 146MMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237053 ALINITY C PROCESSING MODULE AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT GMBH 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY C ICT - SODIUM| ALINITY C ICT - SODIUM