BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 10517701 · Received September 10, 2020

    Report

    Report Number
    2016493-2020-05374
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Report Date
    July 27, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403222054
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SUPPORT TROUBLESHOOT WITH THE CUSTOMER OVER THE PHONE AND CONFIRMED 8100 ERROR 210.5020 TECH SUPPORT- REPLACE LOGIC BOARD; USED KA 12137 ALARIS INFUSION ERROR 210.5020. RECOMMENDED TO REPLACE THE LOGIC BOARD OR SEND UNIT IN FOR FLAT RATE REPAIR. BIOMED WILL GET A PO AND CALL BACK FOR RMA REPAIR. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM (B)(6) 2011 TO 9/16/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT WAS UNABLE TO DETERMINE THE PROXIMATE CAUSE OF THE REPORTED ISSUE. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. BASED ON THE FILE REVIEW, NO FURTHER ESCALATION IS REQUIRED PER 1501-006-000 SWI-SD-INF COMPLAINT ESCALATIONS, INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. THERE WERE NO EXISTING CAPA¿S LISTED FOR ANY OF THE PARTS LISTED IN THIS FILE FOR REPAIR.

    Additional Manufacturer Narrative · 0

    TECHNICAL SUPPORT TROUBLESHOOT WITH THE CUSTOMER OVER THE PHONE AND CONFIRMED 8100 ERROR 210.5020. TECH SUPPORT- REPLACE LOGIC BOARD; USED KA 12137 ALARIS INFUSION ERROR 210.5020. RECOMMENDED TO REPLACE THE LOGIC BOARD OR SEND UNIT IN FOR FLAT RATE REPAIR. BIOMED WILL GET A PO AND CALL BACK FOR RMA REPAIR. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM (B)(6) 2011 TO (B)(6) 2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT WAS UNABLE TO DETERMINE THE PROXIMATE CAUSE OF THE REPORTED ISSUE. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. BASED ON THE FILE REVIEW, NO FURTHER ESCALATION IS REQUIRED PER 1501-006-000 SWI-SD-INF COMPLAINT ESCALATIONS, INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. THERE WERE NO EXISTING CAPA¿S LISTED FOR ANY OF THE PARTS LISTED IN THIS FILE FOR REPAIR.

    Description of Event or Problem · 0

    CASE #: (B)(4). CASE SUBJECT: (B)(6). ACCOUNT NAME: (B)(6). ACCOUNT #: (B)(4). ASSET NAME: 8100 PUMP MODULE V8.5.29.0. ASSET LOCATION: CONTACT: (B)(6). CONTACT EMAIL: (B)(6). CONTACT PHONE: (B)(6). CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO. PATIENT OR USER HARM: NO. CASE DESCRIPTION: CALLER HAS AN 8100 MODULE GIVING A 210.5020 ERROR. SN: (B)(6). FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: REPLACE LOGIC BOARD; USED KA 12137 ALARIS INFUSION ERROR 210.5020. RECOMMENDED TO REPLACE THE LOGIC BOARD OR SEND UNIT IN FOR FLAT RATE REPAIR. BIOMED WILL GET A PO AND CALL BACK FOR RMA REPAIR.

    Description of Event or Problem · 0

    CASE #: (B)(4). CASE SUBJECT: NPI 8100 ERROR 210.5020 ACCOUNT NAME: (B)(6) HOSPITAL. ACCOUNT #: (B)(6). ASSET NAME: 8100 PUMP MODULE V8.5.29.0. ASSET LOCATION: CONTACT: (B)(6). CONTACT EMAIL: (B)(6). CONTACT PHONE: (B)(6). CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO. PATIENT OR USER HARM: NO. CASE DESCRIPTION: CALLER HAS AN 8100 MODULE GIVING A 210.5020 ERROR. SN: (B)(6). FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: REPLACE LOGIC BOARD; USED KA 12137 ALARIS INFUSION ERROR 210.5020. RECOMMENDED TO REPLACE THE LOGIC BOARD OR SEND UNIT IN FOR FLAT RATE REPAIR. BIOMED WILL GET A PO AND CALL BACK FOR RMA REPAIR.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SYSTEM ERROR. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982183 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403222054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown