BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S SYSTEM

    MDR report key: 18764259 · Received February 22, 2024

    Report

    Report Number
    1628664-2024-00004
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    July 6, 2023
    Report Date
    February 22, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZA
    UDI-DI
    00380740138479
    Removal / Correction Number
    1628664-02/14/2024-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FOR SECTION D4 AND H4: D4 SERIAL #: (B)(6). D4 UNIQUE IDENTIFIED (UDI)# (B)(4). H4 DEVICE MFG DATE: 12/13/2017. D4 SERIAL #: (B)(6). D4 UNIQUE IDENTIFIED (UDI)# (B)(4). H4 DEVICE MFG DATE: 08/03/2018. D4 SERIAL #: (B)(6). D4 UNIQUE IDENTIFIED (UDI)# (B)(4). H4 DEVICE MFG DATE: 10/02/2018. D4 SERIAL #: (B)(6). D4 UNIQUE IDENTIFIED (UDI)# (B)(4). H4 DEVICE MFG DATE: 10/25/2018. D4 SERIAL #: (B)(6). D4 UNIQUE IDENTIFIED (UDI)# (B)(4). H4 DEVICE MFG DATE: 11/12/2019. D4 SERIAL #: (B)(6). D4 UNIQUE IDENTIFIED (UDI)# (B)(4). H4 DEVICE MFG DATE: 11/24/2021. D4 SERIAL #: (B)(6). D4 UNIQUE IDENTIFIED (UDI)# (B)(4). H4 DEVICE MFG DATE: 06/24/2022. THE INVESTIGATION INTO THIS ISSUE CONFIRMED THERE IS NO FAILURE TO MEET DESIGN INPUTS OR PRODUCT REQUIREMENTS. THE USE OF AN EXTERNAL WASTE PUMP NOT INTENDED FOR USE WITH THE ALINITY S SYSTEM DOES NOT IMPACT THE FUNCTIONALITY OF THE INSTRUMENT. THE CAUSE OF THE ISSUE IS DUE TO HUMAN ERROR AS THE SERVICE PERSONNEL DID NOT CHECK THE PUMP PART NUMBER IN THE GLOBAL PRODUCT PART MASTER (GPPM) DATABASE BEFORE INSTALLING TO ENSURE THE PART IS LINKED TO THE ALINITY S SYSTEM. A PRODUCT CORRECTION LETTER WAS ISSUED ON 08FEB2024 TO THE ALINITY S SYSTEM CUSTOMERS WHO HAVE THE ABBOTT EXTERNAL WASTE PUMP CONNECTED TO THEIR ALINITY S SYSTEM. THE PRODUCT CORRECTION LETTER NOTIFIES THEM OF THE ISSUE, POTENTIAL IMPACT TO USER SAFETY, AND PROVIDES THE CUSTOMER OF LIQUID WASTE SPECIFICATIONS, WHICH WILL BE INCLUDED IN A FUTURE VERSION OF THE ALINITY S SYSTEM OPERATIONS MANUAL. ADDITIONALLY, THE PRODUCT CORRECTION LETTER INFORMS THE CUSTOMER THEIR ABBOTT REPRESENTATIVE WILL CONTACT THEM TO DISCUSS WASTE DRAINAGE OPTIONS WITHIN THE LABORATORY AND SCHEDULE A DISCONNECTION OF THE EXTERNAL WASTE PUMP FROM THE WASTE LINE OF THE ALINITY S SYSTEM. THE LETTER ALSO CONTAINS THE NECESSARY ACTIONS FOR THE CUSTOMER TO TAKE IF FOAMING/BUBBLING/LEAKING OCCUR, WHICH INCLUDES: ENSURING THE FLOOR IS DRY AND CLEAN UNDER AND AROUND THE ALINITY S SYSTEM(S) AND THE EXTERNAL WASTE PUMP(S); USE GOOD LABORATORY TECHNIQUES AND ALWAYS WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN OPERATING THE ALINITY S SYSTEM(S); AND REFER TO HAZARDS SECTION IN THE ALINITY S SYSTEM OPERATIONS MANUAL FOR SPILL CLEANUP SHOULD WASTE ESCAPE ONTO THE FLOOR.

    Description of Event or Problem · 0

    ABBOTT HAS IDENTIFIED AN ISSUE WHERE AN ABBOTT EXTERNAL WASTE PUMP, NOT INTENDED FOR USE WITH THE ALINITY S SYSTEM, WAS INSTALLED ON SEVEN DISTRIBUTED ALINITY S SYSTEMS. THE ISSUE WAS INITIALLY IDENTIFIED VIA TROUBLESHOOTING OF A HIGH PRESSURE MESSAGE CODE ON A DISTRIBUTED ALINITY S SYSTEM. AN ABBOTT EXTERNAL WASTE PUMP WAS INSTALLED TO RESOLVE THE ISSUE. DURING DOCUMENTATION OF THE ISSUE, IT WAS IDENTIFIED THAT THE EXTERNAL WASTE PUMP IS NOT INTENDED FOR USE WITH THE ALINITY S SYSTEM. A FIELD DATA REVIEW CONCLUDED A TOTAL OF SEVEN EXTERNAL AND EIGHT INTERNAL ANALYZERS WITH AN ABBOTT EXTERNAL WASTE PUMP CONNECTED. THERE IS A POTENTIAL FOR LEAKAGE OR FOAMING AT THE EXTERNAL WASTE PUMP(S) WHICH COULD RESULT IN LIQUID ESCAPING THE PUMP ONTO THE FLOOR; THUS, THE POTENTIAL EXISTS FOR A PHYSICAL/OPERATOR INJURY (SLIP / FALL) AND/OR BIOHAZARD EXPOSURE DUE TO LIQUID WASTE ON THE FLOOR AROUND THE EXTERNAL WASTE PUMP(S). THERE HAVE BEEN NO OCCURRENCES OF OPERATOR INJURY OR BIOHAZARD EXPOSURE AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259579 ALINITY S SYSTEM TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN MZA ABBOTT LABORATORIES 00380740138479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown