BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20133205 · Received September 4, 2024

    Report

    Report Number
    2016493-2024-35156
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    April 24, 2024
    Report Date
    October 8, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY: THE COMPLAINT OF A SYRINGE MODULE VOLUME DISCREPANCY WAS IDENTIFIED AS DUE TO USER PROGRAMMING. ALTHOUGH LOG REVIEW SHOWED ¿TERUMO 10ML¿ SYRINGE WAS SELECTED FOR USE, THE RETURNED PICTURE SHOWED A BD 10ML SYRINGE WAS ACTUALLY INSTALLED. ¿ THE PRINTED PICTURE THAT WAS RETURNED WITH THE DEVICE FOR INVESTIGATION SHOWED A BD 10ML SYRINGE WITH THE PLUNGER SET TO APPROXIMATELY 1ML WAS LOADED INTO THE SYRINGE MODULE, BUT THE PCU DISPLAYED OML AS THE AVAILABLE VOLUME. ¿ REVIEW OF THE SYRINGE MODULE EVENT LOG SHOWED, ON (B)(6) 2024 AT 1:04 PM, THE SYRINGE MODULE WAS SELECTED AND PROGRAMMED A SYRINGE TYPE OF TERUMO 10ML (AVAILABLE VOLUME :10.5753 ML) OF AN UNKNOWN MEDICATION TO INFUSE AT A RATE OF 10 ML/HR (VTBI: 0.65 ML). O AT T08 PM, THE INFUSION COMPLETED. O AT 1:09 PM, THE SYRINGE MODULE WAS SELECTED AND PROGRAMMED AN INFUSION AT A RATE OF 99 ML/HR (VTBI: 9.86 ML) O AT 1.15 PM, THE INFUSION COMPLETED O AT 1 16 PM, THE SYRINGE MODULE WAS SELECTED AND PROGRAMMED VTBI OF 0.0053 ML TO INFUSE AT A RATE OF 99 ML/HR O LESS THAN THIRTY (30) SECONDS LATER, THE INFUSION COMPLETED. ¿ REVIEW OF THE LOGS COULD NOT DETERMINE THE VOLUME IN THE SYRINGE AT THE END OF INFUSION ¿ REVIEW OF THE SYRINGE MODULE ERROR LOG SHOWED NO ERRORS WERE RECORDED ON THE REPORTED EVENT DATE. ¿ THE EVENT PCU AND ITS ASSOCIATED LOGS WERE NOT RETURNED FOR INVESTIGATION; THEREFORE, SOME PROGRAMMING PARAMETERS AND DRUG INFORMATION COULD NOT BE CONFIRMED ¿ LABORATORY TESTING OF THE RETURNED SYRINGE MODULE SHOWED THE DEVICE WAS ACCURATELY DETECTING SYRINGE TYPE AND AVAILABLE VOLUME WITHIN SPECIFICATION ROOT CAUSE: THE ROOT CAUSE OF THE COMPLAINT OF SYRINGE MODULE VOLUME DISCREPANCY WAS IDENTIFIED AS USER PROGRAMMING. ALTHOUGH THE PROVIDED PICTURE SHOWED THE SYRINGE MODULE WAS LOADED WITH A BD 10ML SYRINGE, LOG REVIEW SHOWED THE USER SELECTED TERUMO 10ML DURING INFUSION PROGRAMMING

    Additional Manufacturer Narrative · 0

    PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE PUMP MODULE WAS PROGRAMMED TO INFUSE NORMAL SALINE FOR 99ML/HR AND IT SHOWED 9.86ML AVAILABLE IN THE FLUSH SYRINGE. AFTER A FEW MINUTES, THE PUMP BEEPED COMPLETED BUT THERE WAS 1ML LEFT IN THE NORMAL SALINE FLUSH TO BE INFUSED. WHEN TRYING TO ADD VOLUME, THE PUMP READ THE VOLUME TO BE INFUSED AS 0ML AND WOULD NOT ALLOW THE CUSTOMER TO CHANGE THE VALUE, AS IT SAID 1ML "EXCEEDS REMAINING AMOUNT OF 0ML." THE PUMP WAS SET BACK TO THE ACCURATE READING AND THE REMAINING DRUG INFUSED THROUGH THE LINE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE PUMP MODULE WAS PROGRAMMED TO INFUSE NORMAL SALINE FOR 99ML/HR AND IT SHOWED 9.86ML AVAILABLE IN THE FLUSH SYRINGE. AFTER A FEW MINUTES, THE PUMP BEEPED COMPLETED BUT THERE WAS 1ML LEFT IN THE NORMAL SALINE FLUSH TO BE INFUSED. WHEN TRYING TO ADD VOLUME, THE PUMP READ THE VOLUME TO BE INFUSED AS 0ML AND WOULD NOT ALLOW THE CUSTOMER TO CHANGE THE VALUE, AS IT SAID 1ML "EXCEEDS REMAINING AMOUNT OF 0ML." THE PUMP WAS SET BACK TO THE ACCURATE READING AND THE REMAINING DRUG INFUSED THROUGH THE LINE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065205 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown