BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11385494 · Received February 26, 2021

    Report

    Report Number
    2016493-2021-28145
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 2, 2021
    Report Date
    February 16, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE INSPECTION: THE PUMP MODULE WAS RECEIVED WITH THE INSTRUMENT SEAL INTACT. THERE WERE NO OTHER SIGNIFICANT ANOMALIES OBSERVED INTERNALLY OR EXTERNALLY ON THE PUMP MODULE. BOTH IUI CONNECTORS CONTACT PINS WERE FOUND TO BE DULL. BEZEL DATE CODE: (B)(6) 2014 (AFFECTED BY RECALL (B)(6) 2011 ¿ (B)(6) 2017) ALL POSSIBLE REPLACEMENT PARTS WERE OBSERVED TO BE BD PARTS. LOG ANALYSIS RESULTS: RESULTS FROM A REVIEW OF THE PUMP MODULE EVENT LOG IDENTIFIED AN UNKNOWN INFUSION PROGRAMMED AT 9:18:39 AM ON (B)(6) 2021, WITH THE RATE OF 2ML/H AND A VTBI OF 50ML AND WAS STARTED. THE DEVICE WAS CHANNELED OFF ON 3 SEPARATE INSTANCES. THE FIRST AT 11:40:06 AM WITH THE INFUSION BEING RESTORED AND STARTED AT 1:22:22 PM. THE SECOND AT 4:10:08 PM WITH THE INFUSION BEING RESTORED AND STARTED AT 4:28:18 PM. THE 3RD AND FINAL INSTANCE BEING AT 4:36:37 PM. PUMP MODULE ERROR LOGS HAD NO ENTRIES PERTAINING TO THE REPORTED ACCURACY ISSUE. TEST RESULTS: TIMED RATE ACCURACY TESTING PERFORMED ON THE SOURCE PUMP MODULE ATTACHED TO THE LAB PCU, FOUND THE PUMP MODULE DELIVERING FLUID WITHIN SPECIFICATION. NO TESTING WAS PERFORMED ON THE CUSTOMER PCU. TEST METHODS: ALARIS SYSTEM OVER INFUSION (DIR 10000360063) TEST METHOD 1503-001-006-R TIMED RATE ACCURACY TEST METHOD DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 06/24/2014. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SERIAL NUMBER 14135073 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 IN TRACKWISE AND SAP WAS PERFORMED FOR THE SERIAL NUMBER 14449048 WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT OF AN OVER INFUSION OF VERSED WAS NOT DETERMINED. THE CUSTOMER PUMP MODULE DEMONSTRATED TO BE OPERATING AS INTENDED, IN SPECIFICATION. THE CUSTOMER¿S EXPERIENCE WITH A VERSED OVER INFUSION WAS NOT CONFIRMED DURING A REVIEW OF THE LOGS OR DURING THE INVESTIGATION TESTING PERFORMED. RESULTS FROM A REVIEW OF THE PUMP MODULE EVENT LOG IDENTIFIED AN UNKNOWN INFUSION PROGRAMMED AT 9:18:39 AM ON (B)(6) 2021, WITH THE RATE OF 2ML/H AND A VTBI OF 50ML AND WAS STARTED. THE DEVICE WAS CHANNELED OFF ON 3 SEPARATE INSTANCES. THE FIRST AT 11:40:06 AM , THE SECOND AT 4:10:08 PM, AND THE 3RD AND FINAL INSTANCE BEING AT 4:36:37 PM.. BOTH THE INTERNAL AND EXTERNAL INSPECTION OF THE PUMP MODULE FOUND THE DEVICE IN GOOD WORKING CONDITION. FUNCTIONAL TESTING PERFORMED, CONSISTING OF A TIMED RATE ACCURACY TEST ON THE RETURNED PUMP MODULE FOUND THE DEVICE IN GOOD WORKING CONDITION AND DELIVERING FLUID WITHIN SPECIFICATION. THE DEVICE WAS BEING USED FOR TREATMENT. SERVICE WILL BE INSTRUCTED TO REPLACE THE MECHANISM ASSEMBLY AS IT WAS DISASSEMBLED DURING THE INVESTIGATION. MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO CAD, THE SERVICE DEPOT, OR THE CUSTOMER. MANUFACTURING TESTS INVOLVE AN OCCLUDER SPRING TEST, AN X-RAY SPRING INSPECTION AND INSTALL OF NEW ONE-TIME USE TORQUE SCREWS WITH APPLIED TAMPER SEAL MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS SET TO DELIVER 1ML/HR OF VERSED. WHEN THE NURSE WENT TO ASSESS THE PATIENT IN THE AFTERNOON, THE VERSED BAG WAS ALMOST EMPTY. WHEN THE TUBING WAS ASSESSED, IT WAS DISCOVERED THAT THE MEDICATION WAS INFUSING FASTER THAN 1ML/HR. THE MEDICATION WAS IMMEDIATELY STOPPED. THE PATIENT WAS ASSESSED AND FOUND TO BE THE SAME AS PRIOR TO THE ASSESSMENT. PHARMACY, SURGERY, AND INTENSIVE CARE UNIT (ICU) MANAGER WERE NOTIFIED AFTER THE ASSESSMENT. IT WAS NOTED THAT THE PLAN WAS TO HOLD OFF ON ANY SEDATION MEDICATION AND TO CONTINUE TO MONITOR THE PATIENT CLOSELY. THE PUMP WAS REMOVED AND SET ASIDE TO BE INVESTIGATED. THE EVENT OCCURRED IN THE ICU.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL PATIENT DEMOGRAPHICS WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS SET TO DELIVER 1ML/HR OF VERSED. WHEN THE NURSE WENT TO ASSESS THE PATIENT IN THE AFTERNOON, THE VERSED BAG WAS ALMOST EMPTY. WHEN THE TUBING WAS ASSESSED, IT WAS DISCOVERED THAT THE MEDICATION WAS INFUSING FASTER THAN 1ML/HR. THE MEDICATION WAS IMMEDIATELY STOPPED. THE PATIENT WAS ASSESSED AND FOUND TO BE THE SAME AS PRIOR TO THE ASSESSMENT. PHARMACY, SURGERY, AND INTENSIVE CARE UNIT (ICU) MANAGER WERE NOTIFIED AFTER THE ASSESSMENT. IT WAS NOTED THAT THE PLAN WAS TO HOLD OFF ON ANY SEDATION MEDICATION AND TO CONTINUE TO MONITOR THE PATIENT CLOSELY. THE PUMP WAS REMOVED AND SET ASIDE TO BE INVESTIGATED. THE EVENT OCCURRED IN THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284657 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 PRI TUBING,8015,THERAPY DATE 02/02/2021| PRI TUBING,8015,THERAPY DATE 02/02/2021