BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10933006 · Received December 2, 2020

    Report

    Report Number
    2016493-2020-53948
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Report Date
    November 6, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER¿S REPORTED COMPLAINT OF SEVERAL BROKEN BEZELS WAS CONFIRMED ON 15 BEZEL ASSEMBLIES DURING THE INSPECTION OF THE RETURNED COMPONENTS. ALL INSPECTED BEZEL ASSEMBLIES CONTAINED THE DATE CODES OF (B)(6) 2014, AND (B)(6) 2016. INSPECTION: 15 BEZEL ASSEMBLIES P/N 49000204 WERE INSPECTED. OBSERVED CRACKS ON THE LOWER HINGES OF THE BEZEL ASSEMBLIES. DAMAGE HAS ALSO BEEN OBSERVED IN VARIOUS PLACES SUCH AS CRACKS IN THE UPPER HINGE, CRACKS IN BETWEEN THE LATCH YOKE NEST & PRIMARY PUMPING FINGER SLOT, AND CRACKS AT THE YOKE. LOG ANALYSIS RESULTS: N/A ¿ LOGS WERE NOT DEEMED NECESSARY FOR THIS INVESTIGATION. TEST RESULTS: N/A ¿ TESTING WAS NOT DEEMED NECESSARY FOR THIS INVESTIGATION. DEVICE HISTORY REVIEW: PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 3 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 10 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 18 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 3 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N(B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 14 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 13 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 19 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 14 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 19 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 13 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 18 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 14 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 4 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 14 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. PUMP S/N (B)(4) DEVICE WAS MANUFACTURED ON 13 JUNE 2014. THERE ARE NO RECORDS OF PUMP S/N (B)(4) BEING SENT IN FOR REPAIR. NO QNS WERE FOUND TO HAVE BEEN OPENED ON THIS DEVICE DURING MANUFACTURING. REVIEW OF THE QN DATABASE WAS PERFORMED FOR THE BEZEL ASSEMBLY P/N 49000270. THE DATABASE SHOWED 2 QUALITY NOTIFICATIONS LVP DEFECTIVE INSERT KITS AND SCREWS NOT FULLY SEATED. THIS IS NOT RELATED TO THE CUSTOMER¿S REPORTED ISSUE OF CRACKED HINGES. ADDITIONAL COMMENTS: S/N (B)(4) DATE CODE: MAR 2014 ADDITIONAL COMMENTS 2: DATE CODE: APR 2014. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED. THE CUSTOMER STATED THAT THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY HAD APPROXIMATELY 30 OR 40 DAMAGED DOOR HINGES (BEZEL PART # 49000270) WHERE THE HINGE CRACKS AND THE DOOR BREAKS OFF. HISTORICAL CORRECTIVE ACTION TAKEN: 1ST VISIT (B)(6) 2017, A REMEDIATION TEAM CAME OUT FROM BD AND REPLACED SEVERAL OF PART # 49000270; 2ND VISIT (B)(6) 2017, A REMEDIATION TEAM CAME OUT FROM BD AND REPLACED 241 OF PART# 49000270 ACCORDING TO CUSTOMER. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397941 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1