BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11221024 · Received January 24, 2021

    Report

    Report Number
    2016493-2021-16255
    Event Type
    Malfunction
    Date Received
    January 24, 2021
    Date of Event
    May 6, 2020
    Report Date
    May 18, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE THAT IV TUBING WITH AN UNKNOWN MEDICATION IS CAUSING LOTS OF AIR BUBBLES MAKING PUMPS ALARM COULD NOT BE CONFIRMED; NO PRODUCT OR DEVICE LOGS WERE RETURNED FOR INVESTIGATION. THE FILE WAS OPENED TO DOCUMENT THE ISSUE THAT WAS REPORTED. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME. NO DEVICE HISTORY OR QN SEARCH WAS PERFORMED FOR THE SUSPECT PUMP MODULE SINCE NO DEVICE SERIAL NUMBER WAS REPORTED BY THE CUSTOMER. THE ALARIS SYSTEM IS TYPICALLY USED FOR TREATMENT. THE FILE MAY BE CLOSED BASED ON THE ABOVE FACTS. 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 · 0

    IT WAS REPORTED FROM OUTPATIENT INFUSION SERVICES THAT IV TUBING WITH AN UNKNOWN MEDICATION IS CAUSING LOTS OF AIR BUBBLES MAKING PUMPS ALARM. THE EVENT RESULTED IN A DELAY IN CARE FOR THE PATIENT. THE PUMP WOULD ALLOW LARGER AIR BUBBLES TO PASS THROUGH BUT THE TINY AIR BUBBLES WOULD CAUSE THE PUMP TO ALARM. THEN, THE PUMP WOULD ALARM WHEN NO VISIBLE BUBBLE/AIR WAS IN LINE. MULTIPLE RNS WOULD TRY TO TROUBLESHOOT BY CHANGING THE TUBING THREE TIMES, CHANGING PUMPS THREE TIMES AND CHANGING CHANNELS THREE TIMES. THERE WAS NO ADVERSE EFFECTS CAUSED TO THE PATIENT AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE THAT IV TUBING WITH AN UNKNOWN MEDICATION IS CAUSING LOTS OF AIR BUBBLES MAKING PUMPS ALARM COULD NOT BE CONFIRMED; NO PRODUCT OR DEVICE LOGS WERE RETURNED FOR INVESTIGATION. THE FILE WAS OPENED TO DOCUMENT THE ISSUE THAT WAS REPORTED. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME. NO DEVICE HISTORY OR QN SEARCH WAS PERFORMED FOR THE SUSPECT PUMP MODULE SINCE NO DEVICE SERIAL NUMBER WAS REPORTED BY THE CUSTOMER. THE ALARIS SYSTEM IS TYPICALLY USED FOR TREATMENT. THE FILE MAY BE CLOSED BASED ON THE ABOVE FACTS. 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

    IT WAS REPORTED FROM OUTPATIENT INFUSION SERVICES THAT IV TUBING WITH AN UNKNOWN MEDICATION IS CAUSING LOTS OF AIR BUBBLES MAKING PUMPS ALARM. THE EVENT RESULTED IN A DELAY IN CARE FOR THE PATIENT. THE PUMP WOULD ALLOW LARGER AIR BUBBLES TO PASS THROUGH BUT THE TINY AIR BUBBLES WOULD CAUSE THE PUMP TO ALARM. THEN, THE PUMP WOULD ALARM WHEN NO VISIBLE BUBBLE/ AIR WAS IN LINE. MULTIPLE RNS WOULD TRY TO TROUBLESHOOT BY CHANGING THE TUBING THREE TIMES, CHANGING PUMPS THREE TIMES AND CHANGING CHANNELS THREE TIMES. THERE WAS NO ADVERSE EFFECTS CAUSED TO THE PATIENT AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117476 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015, 20200506