BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11054469 · Received December 22, 2020

    Report

    Report Number
    2016493-2020-71436
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 24, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2736-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMER¿S REPORTED COMPLAINT OF THE PUMP MODULE OVER INFUSED WAS NOT REPRODUCED. TESTING SHOWS THE DEVICE IS INFUSING PROPERLY. BASED ON THE LOGS, A GUARDRAILS DRUGS INFUSION OF DRUGID=122 (CYCLOPHOSPHAMIDE) WAS PROGRAMMED AT 8:05:01PM ON 05NOV2020, AT DRUG AMOUNT OF 477MG, DILUENT VOLUME OF 250ML, RATE OF 83.3ML/H AND A VTBI OF 250ML. THE PUMP MODULE INFUSED UNTIL 11:05:09PM WHEN THE INFUSION WENT INTO KVO (KVO=20ML/HR). THE USER UPDATES THE GUARDRAILS DRUGS INFUSION OF DRUGID=122 AT 11:06:40PM TO INFUSE AT A VTBI OF 20ML AND THEN AGAIN AT 11:06:51PM TO INFUSE AT A VTBI OF 60ML. THE PUMP MODULE IS PAUSES AT 11:26:18PM AND THEN CHANNELED OFF AT 11:26:20PM. DURING THIS PERIOD, THE PUMP MODULE ALARMED 3 TIMES FOR AIR IN LINE AND ONCE FOR DOOR OPENED. THE INFUSION WAS RESTARTED AFTER EACH INSTANCE. THE TOTAL VOLUME INFUSED FOR THE FIRST 3HOURS AND THEN THE ADDITIONAL 20 MINUTES WAS 277.378ML. TEST RESULTS FROM THE TIMED RATE ACCURACY TEST METHOD PERFORMED ON THE SOURCE DEVICE CONFIRMED THE PUMP MODULE IS WITHIN SPECIFICATION AND OPERATING AS INTENDED. THE SOURCE PUMP MODULES MOTOR MOUNT WAS OVERSERVED TO BE BROKEN, THIS IS CONSIDERED AN INCIDENTAL FIND AND NOT RELEVANT TO THIS INVESTIGATION. DEVICE INSPECTION: PUMP MODULE WAS RECEIVED WITH THE INSTRUMENT SEAL INTACT. DOOR HINGES ARE INTACT AND FUNCTIONAL. PLATEN, POSTS/HINGE, PINS/SPRINGS BUTTONS ARE ALL INTACT AND NOT INTERFERING WITH DOOR OPERATION. DOOR LATCH/SEAR AND PIVOT LATCH SCREW IS INSTALLED AND NOT INTERFERING WITH DOOR OPERATION. THE RIGHT (MALE) IUI WAS OBSERVED WITH DAMAGED ISOLATION RIBS AND DRY FLUID RESIDUE. THE LEFT (FEMALE) IUI WAS OBSERVED TO BE IN GOOD CONDITION. ALL PARTS INSPECTED COMPONENTS WERE OBSERVED TO BE BD MANUFACTURED PARTS. AN EXTERNAL AND INTERNAL INSPECTION OF THE CUSTOMER¿S PUMP MODULE EXHIBITED THE FOLLOWING: FLUID INGRESS WAS OBSERVED UNDER MALE IUI REAR CASE CAVITY. FLUID INGRESS WAS ALSO OBSERVED UNDER THE PLATEN ASSEMBLY, MEMBRANE AND BELOW THE AIR IN LINE SENSOR ASSEMBLY. IT WAS OBSERVED THAT THE MOTOR MOUNT WAS BROKEN. NO CONTAMINATION WAS OBSERVED ON THE MECHANISM ASSEMBLY. OVERALL, THE INTERNAL COMPONENTS AND CABLE CONNECTIONS WERE OBSERVED IN GOOD CONDITION. NO OTHER OBVIOUS ISSUES OR ANOMALIES WERE IDENTIFIED WITH THE SOURCE DEVICE DURING THE INTERNAL INSPECTION. THE INCIDENT ADMINISTRATION SET WAS NOT RETURNED AND COULD NOT BE INSPECTED. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THE CUSTOMER REPORT OF THE PUMP MODULE OVER INFUSED WAS NOT DETERMINED. CUSTOMER¿S RETURNED SOURCE DEVICE WAS CONFIRMED OPERATING WITHIN SPECIFICATION BASED ON THE TEST RESULTS. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 02FEB2018. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR PUMP MODULE (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR THE PUMP MODULE (B)(6)WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS AN OVER INFUSION OF CYTOXAN STARTED AT 2004, TO LAST 3 HOUR HOURS. "THE INFUSION COMPLETED AT 2340 (36 MINUTES OVER). 250ML WAS ORDERED, 293.38 INFUSED ACCORDING TO PUMP (INCLUDES 16ML FLUSH), 17% OVER. TESTED 10X AT PRESCRIBED RATE/DOSE AND DELIVERED ACCURATELY ALL BUT ONCE (SEE TESTING BOOK)." THERE WAS NO PATIENT HARM REPORTED. ALTHOUGH REQUESTED FURTHER INFORMATION WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. ALTHOUGH REQUESTED FURTHER INFORMATION WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN OVER INFUSION OF CYTOXAN STARTED AT 2004, TO LAST 3 HOUR HOURS. "THE INFUSION COMPLETED AT 2340 (36 MINUTES OVER). 250ML WAS ORDERED, 293.38 INFUSED ACCORDING TO PUMP (INCLUDES 16ML FLUSH), 17% OVER. TESTED 10X AT PRESCRIBED RATE/DOSE AND DELIVERED ACCURATELY ALL BUT ONCE (SEE TESTING BOOK)." THERE WAS NO PATIENT HARM REPORTED. ALTHOUGH REQUESTED FURTHER INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520174 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 PRI TUBING,8015, TD 11/05/2020