BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20438420 · Received October 14, 2024

    Report

    Report Number
    2016493-2024-38906
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 13, 2024
    Report Date
    October 30, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811043
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: E2321 - LOW BLOOD PRESSURE/ HYPOTENSION, F24 - INSUFFICIENT INFORMATION, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION: DESCRIBE EVENT OR PROBLEM. ADDITIONAL INFORMATION: IMDRF ANNEX E, F, A, B, C, D, G CODES AND 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 REPORTED ISSUE OF A CHANNEL DISCONNECT WAS CONFIRMED VIA LOG ANALYSIS; HOWEVER, THE CAUSE COULD NOT BE IDENTIFIED FROM THE LOG AND PHOTO ONLY INVESTIGATION. ¿ THE EXTERNAL AND INTERNAL INSPECTION OF THE DEVICES COULD NOT BE PERFORMED AS NO DEVICES, WERE RETURNED FOR INSPECTION, HOWEVER, THE CUSTOMER PROVIDED LOGS, PICTURES AND DATA OF THE ISSUE THEY EXPERIENCED AS EVIDENCE. ¿ THE CUSTOMER, ALONG WITH THE BD TEAM, CONDUCTED A SERIES OF FUNCTIONAL TESTS. THE RESULTS OBTAINED WERE INCONCLUSIVE, AS THE CHANNEL DISCONNECTION ERROR WAS REPORTED TO BE INTERMITTENT. ¿ THE REVIEW OF THE SYRINGE ERROR LOG SHOWED NO RECORDED ERRORS OR MALFUNCTIONS ON THE REPORTED DATE. ¿ THE SYRINGE MODULE EVENT LOG POWERED ON 13SEP2024 AT 17:57 PM; THE SYRINGE MODULE S/N (B)(6) WAS CONNECTED AS CHANNEL A. ¿ AT 19:30 PM, SYRINGE MODULE S/N (B)(6) WAS SELECTED, AND A REMOTE IV ORDER WAS RECEIVED FOR (UNKNOWN DRUG AT 2000MCG/1ML) TO INFUSE AT THE RATE=0.54 ML/H WITH THE VOLUME TO BE INFUSED (VTBI) OF 5 ML. ¿ THE REVIEW OF THE EVENT LOG SHOWED NO RECORDED ENTRIES OF THE SOURCE DEVICE BEING POWERED UP AFTER THE CHANNEL DISCONNECT EVENT THAT OCCURRED ON 13SEP2024 AT 16:00 ¿ 19:49. ¿ THE ALARIS SYSTEM USER MANUAL (V12.1), STATES WITHIN INSPECTION REQUIREMENTS, ¿TO ENSURE THAT THE BD ALARISTM SYSTEM REMAINS IN GOOD OPERATING CONDITION, BOTH REGULAR AND PREVENTATIVE MAINTENANCE INSPECTIONS ARE REQUIRED.¿ ¿ THE DEVICE WAS REPORTEDLY IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198 (D)(2). ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED CHANNEL DISCONNECT WAS NOT ABLE TO BE IDENTIFIED FROM THE INFORMATION MADE AVAILABLE (LOGS AND PHOTOS ONLY).

    Additional Manufacturer Narrative · 0

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. 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 ALARIS SYRINGE PUMP MODULE WAS ATTACHED AND BEING HOOKED UP TO PATIENT'S NEWLY INSERTED PICC LINE. THE PUMP MODULE WAS CONNECTED AS MODULE A, SHOWED AS INFUSING DOBUTAMINE AT 5MCG/KG/MIN AT 0.54ML/HR. WHEN THE WRITER CHECKED THE SECTION OF THE PUMP THAT WAS TO BE INFUSING, MODULE A WAS NOT REGISTERING AND NO VOLUME INFUSED WAS NOTED. THE BLOOD PRESSURE OF THE PATIENT SUBSEQUENTLY DROPPED. RESTARTING AND DISCONNECTING/REATTACHING SYRINGE MODULE DID NOT FIX THE PROBLEM. THE SYRINGE PUMP MODULE REPLACED AND BIOMED REQUEST SENT. THERE WAS PATIENT INVOLVEMENT, AND THE BLOOD PRESSURE OF THE PATIENT WAS MENTIONED TO HAVE DROPPED. A COPY OF THE HEALTH CANADA REPORT WAS RECEIVED, WHICH STATES, "P119535 ALARIS PUMP SYRINGE MODULE WAS ATTACHED AND BEING HOOKED UP TO PATIENT'S NEWLY INSERTED PICC LINE. MODULE CONNECTED AS MODULE A, SHOWED AS INFUSING DOBUTAMINE AT 5MCG/KG/MIN AT 0.54ML/HR. WHEN WRITER CHECKED VOLUME TO BE INFUSED SECTION OF PUMP, MODULE A WAS NOT REGISTERING AND NO VOLUME INFUSED WAS NOTED. BLOOD PRESSURE OF PATIENT SUBSEQUENTLY DROPPED. RESTARTING AND DISCONNECTING/REATTACHING SYRINGE MODULE DID NOT FIX THE PROBLEM. SYRINGE MODULE REPLACED AND BIOMED REQUEST SENT". BD RECEIVED ADDITIONAL INFORMATION. PER CUSTOMER, CHART REVIEW REVEALED "NO DOCUMENTED CONCERNS IN THE CHART ABOUT THE BP (BLOOD PRESSURE) BY THE PHYSICIAN AND THAT THE BP WAS ABOVE THE TARGETED LEVELS ORDERED." THE CUSTOMER ALSO LATER PROVIDED THEIR BIOMED INVESTIGATION FINDINGS SO FAR DOCUMENTED AS FOLLOWS: "-BIOMED RECEIVED THE SYRINGE MODULE (SN (B)(6)) AND WAS ABLE TO CHASE DOWN THE PCU (ECN# P111243, SN: (B)(6)) -BIOMED DOWNLOAD AND INVESTIGATED ERROR AND EVENT LOGS, FOUND RATE 0.5355ML/HR VTBI 7ML -REQUESTED PCU UNIT INVOLVED IN PSLS TO CLINICAL AND WAS ABLE TO RECEIVE CORRESPONDING PCU -DOWNLOAD AND INVESTIGATED ERROR AND EVENT LOGS IN PCU IDENTIFIED SOURCE OF ERROR AS LOGS IN BETWEEN (B)(6) 2024 AT 7:3010 TO 7:30:57 WITH SYRINGE PUMP IDENTIFIED -NOTED THAT THE PRIMARY AND TOTAL VOLUME INFUSED ARE BOTH REGISTERED AS NEGATIVE (-0.0601 AND -0.0556 RESPECTIVELY) WHICH IS NOT USUAL FOR EVENT LOGS"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALARIS SYRINGE PUMP MODULE WAS ATTACHED AND BEING HOOKED UP TO PATIENT'S NEWLY INSERTED PICC LINE. THE PUMP MODULE WAS CONNECTED AS MODULE A, SHOWED AS INFUSING DOBUTAMINE AT 5MCG/KG/MIN AT 0.54ML/HR. WHEN THE WRITER CHECKED THE SECTION OF THE PUMP THAT WAS TO BE INFUSING, MODULE A WAS NOT REGISTERING AND NO VOLUME INFUSED WAS NOTED. THE BLOOD PRESSURE OF THE PATIENT SUBSEQUENTLY DROPPED. RESTARTING AND DISCONNECTING/REATTACHING SYRINGE MODULE DID NOT FIX THE PROBLEM. THE SYRINGE PUMP MODULE REPLACED AND BIOMED REQUEST SENT. THERE WAS PATIENT INVOLVEMENT AND THE BLOOD PRESSURE OF THE PATIENT WAS MENTIONED TO HAVE DROPPED, HOWEVER THE OUTCOME IS UNKNOWN. THIS WAS ALL THE INFORMATION THAT THE CUSTOMER PROVIDED AND HAD INDICATED THAT NO FURTHER INFORMATION WOULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810886 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015