BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11259984 · Received February 1, 2021

    Report

    Report Number
    2016493-2021-22110
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Report Date
    January 28, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED, PROBLEM CODE OF ERROR CODE 211.200 WAS NOT CONFIRMED, OVER THE PHONE. TECH SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE. RECOMMENDED TO REPLACE LOGIC BOARD AND RETURN MODULE. A SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED. H3 OTHER TEXT: TROUBLESHOOTING OVER THE PHONE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED PROBLEM WAS NOT CONFIRMED. TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER TO DETERMINE THE CUSTOMER REPORTED ISSUE OF NPI ERROR CODE 211.200 ON 8100 UNIT. TECHNICAL SUPPORT: 1. TECH CALLED IN WITH ERROR CODE 211.2000 ON 8100 UNIT. 2. WHICH IS A UNSPECIFIED COMMUNICATION ERROR ON UNIT NEEDS TO REPLACE LOGIC BOARD. 3. BEFORE CALL IN TECH HAD ALREADY REPLACE LOGIC BOARD AND STILL GET SAME ERROR CODE. 4. WILL NEED TO SEND UNIT IN FOR SERVICES REPAIR. SYMPTOMS/SYSTEM EFFECT: 8100 MODULE GIVING A 211.2000 ERROR. SOURCE: TECHNICAL SERVICE MANUAL, BD ALARIS¿ PC UNIT, MODEL 8015 AND BD ALARIS¿ PUMP MODULE, MODEL 8100, STEPS TO SOLVE (INTERNAL). SOLUTION/WORKAROUND SUMMARY: HOW TO CORRECT A 211.2000 ERROR. HIGH LEVEL STEPS/PROCEDURE: 1. REPLACE LOGIC BOARD. 2. RETURN THE MODULE TO THE FACTORY. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT DETERMINED THE PROXIMATE CAUSE OF THE CUSTOMER¿S REPORTED ISSUE. 2021-002122-527933 A SERIAL NUMBER WAS NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER TO DETERMINE THE CUSTOMER REPORTED ISSUE OF NPI ERROR CODE 211.200 ON 8100 UNIT. TECHNICAL SUPPORT: 1. TECH CALLED IN WITH ERROR CODE 211.2000 ON 8100 UNIT. 2. WHICH IS A UNSPECIFIED COMMUNICATION ERROR ON UNIT NEEDS TO REPLACE LOGIC BOARD. 3. BEFORE CALL IN TECH HAD ALREADY REPLACE LOGIC BOARD AND STILL GET SAME ERROR CODE. 4. WILL NEED TO SEND UNIT IN FOR SERVICES REPAIR. YMPTOMS/SYSTEM EFFECT: ¿ 8100 MODULE GIVING A 211.2000 ERROR. SOURCE: TECHNICAL SERVICE MANUAL. BD ALARIS¿ PC UNIT, MODEL 8015 AND BD ALARIS¿ PUMP MODULE, MODEL 8100. STEPS TO SOLVE (INTERNAL) SOLUTION/WORKAROUND SUMMARY: ¿ HOW TO CORRECT A 211.2000 ERROR. HIGH LEVEL STEPS/PROCEDURE: 1. REPLACE LOGIC BOARD. 2. RETURN THE MODULE TO THE FACTORY. 2021-002122-527933: A SERIAL NUMBER WAS NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT DETERMINED THE PROXIMATE CAUSE OF THE CUSTOMER¿S REPORTED ISSUE. TECHNICAL SUPPORT: 1. TECH CALLED IN WITH ERROR CODE 211.2000 ON 8100 UNIT. 2. WHICH IS A UNSPECIFIED COMMUNICATION ERROR ON UNIT NEEDS TO REPLACE LOGIC BOARD. 3. BEFORE CALL IN TECH HAD ALREADY REPLACE LOGIC BOARD AND STILL GET SAME ERROR CODE. 4. WILL NEED TO SEND UNIT IN FOR SERVICES REPAIR. YMPTOMS/SYSTEM EFFECT: ¿ 8100 MODULE GIVING A 211.2000 ERROR. SOURCE: TECHNICAL SERVICE MANUAL. BD ALARIS¿ PC UNIT, MODEL 8015 AND BD ALARIS¿ PUMP MODULE, MODEL 8100 STEPS TO SOLVE (INTERNAL) SOLUTION/WORKAROUND SUMMARY: ¿ HOW TO CORRECT A 211.2000 ERROR. HIGH LEVEL STEPS/PROCEDURE: 1. REPLACE LOGIC BOARD. 2. RETURN THE MODULE TO THE FACTORY. 2021-002122-527933: THE CUSTOMER REPORTED PROBLEM WAS NOT CONFIRMED. H3 OTHER TEXT : NO PRODUCT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE DEVICE RECEIVED AN ALARM ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 211.200. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RECEIVED AN ALARM - ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 211.200. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RECEIVED AN ALARM - ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 211.200. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECEIVED AN ALARM - ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 211.200. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154836 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1