BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11611216 · Received April 2, 2021

    Report

    Report Number
    2016493-2021-500308
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    February 28, 2021
    Report Date
    March 9, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF AN OVER INFUSION WAS NOT CONFIRMED. PHYSICAL INSPECTION NOTED THE DEVICE TO BE RECEIVED IN FAIR CONDITION. THE INSTRUMENT SEAL WAS BROKEN. DRIED FLUID OBSERVED ON BOTH THE MALE AND FEMALE IUI. CRUSH MARKS OBSERVED AT THE UPPER FITMENT OF THE TUBE GUIDE WHICH IS INDICATIVE OF A SET MISLOAD. DRIED FLUID OBSERVED INSIDE DOOR. PLATEN ASSEMBLY, POST, HINGE, PINS, SPRINGS, AND BUTTONS ARE ALL INTACT AND DID NOT INTERFERE WITH THE DOOR OPERATION. LATCH SEAR ARE INSTALLED PROPERLY AND DID NOT INTERFERE WITH THE DOOR OPERATION. THE ADMINISTRATION SET WAS NOT RETURNED AND COULD NOT BE INSPECTED. REVIEW OF THE PCU ERROR LOG SHOWED NO ERRORS WERE RECORDED ON THE REPORTED EVENT DATE. ANALYSIS OF THE PCU EVENT LOG SHOWED THE PCU UPLOADED A NEW DATASET AFTER THE REPORTED EVENT. REVIEW OF THE PROVIDED EVENT DATASET SHOWED THE REPORTED MEDICATION PHENYLEPHRINE AS DRUGID=447 IN THE CRITICAL CARE ADULT PROFILE. REVIEW OF THE PCU EVENT LOG SHOWED THE PCU WAS POWERED ON AT 9:44 AM ON (B)(6) 2021. AT 9:49 PM, THE SUSPECT DEVICE WAS ATTACHED TO THE PCU. AT 9:57 PM, THE SUSPECT DEVICE WAS SELECTED AND PROGRAMMED PHENYLEPHRINE (DRUGID= 447) TO INFUSE AT A RATE OF 4ML/HR (VTBI= 75 ML). BETWEEN 9:58 PM AND 10:03 PM, THE SUSPECT DEVICE WAS PAUSED THREE TIMES AND RESTARTED. AT 10:06 PM, THE SUSPECT DEVICE WAS CHANNELED OFF. VOLUME INFUSED= 0.313ML. RATE ACCURACY TESTING RESULTED IN THE DEVICE OPERATING WITHIN SPECIFICATION. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 02/03/2012. 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 SOURCE DEVICE LVP SN (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 FOR THE SOURCE DEVICE LVP SN (B)(6) DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF AN OVER INFUSION WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM SICU THAT ON (B)(6), 2021, A PHENYLEPHRINE OVERINFUSION ALLEGEDLY OCCURRED WHEN A NEW BAG OF PHENYLEPHRINE WAS FOUND NEARLY EMPTY. THE PATIENT WAS ADMITTED FOR A GUNSHOT WOUND AND DIAGNOSED WITH BRAIN HERNIATION AND BRAIN DEATH, AND WAS BEING TRANSITIONED FROM A CONTINUOUS LEVOPHED (NOREPINEPHRINE) INFUSION TO A NEO-SYNEPHRINE (PHENYLEPHRINE) INFUSION. THE INFUSIONS WERE TITRATABLE FOR A BLOOD PRESSURE GOAL OF MEAN ARTERIAL PRESSURE (MAP) GREATER THAN 65. THE BAG OF PHENYLEPHRINE (CONCENTRATION 30MG IN 100ML) WAS STARTED AT 21:58 USING THE CRITICAL CARE ADULT PROFILE FOR A DOSE OF 20MCG/MIN (RATE OF 4ML/H), HOWEVER IT WAS ALLEGEDLY DISCOVERED THAT THE BAG HAD COMPLETELY INFUSED INTO THE PATIENT WITHIN THE FIRST FIVE MINUTES AFTER STARTING PHENYLEPHRINE. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AT 22:05 WHEN THE PATIENT'S HEART RATE JUMPED TO THE 140S AND SYSTOLIC BLOOD PRESSURE UP TO 160S, SO THE NURSE TITRATED THE NOREPINEPHRINE RATE DOWN. AT 22:10 THE PATIENT'S BLOOD PRESSURE INCREASED TO 219/143 WITH A HEART RATE OF 151, AND BOTH THE PHENYLEPHRINE AND NOREPINEPHRINE INFUSIONS WERE STOPPED, AND THE PATIENT WAS MONITORED. UPON STOPPING THESE MEDICATIONS, THE NURSE NOTICED THE NEW BAG OF PHENYLEPHRINE WAS NEARLY EMPTIED. WHEN THE NURSE ASSESSED THE PATIENT, IT WAS DISCOVERED THAT HE HAD COMPLETELY HERNIATED. UPON FURTHER CLARIFICATION BY THE NURSING SUPERVISOR, THE PATIENT WAS ALREADY DECLARED BRAIN DEAD IN THE MORNING PRIOR TO THE EVENT ON (B)(6), 2021 AT 0730, BUT REPORTEDLY COMPLETED HERNIATION DUE TO THE RAPID INCREASE IN BLOOD PRESSURE BECAUSE OF THE EVENT. THE PRIMARY CAUSE OF BRAIN DEATH WAS HERNIATION DUE TO A GUNSHOT WOUND. AN AUTOPSY WAS NOT PERFORMED, AS THE PATIENT WAS AN ORGAN DONOR. THE EVENT DID NOT IMPEDE OR AFFECT THE ORGAN DONATION PROCESS. THE PRIMARY NURSE AND GOH (GIFT OF HOPE, ORGAN DONATION) NURSE DID A DOUBLE CHECK ON THE PUMP SETTINGS, AND VERIFIED THAT THE SETTINGS WERE CORRECT. THE TUBING SET WAS DISCARDED, BUT THE PCU PUMP AND LARGE VOLUME PUMP MODULE WERE SEQUESTERED AND TESTED BY THE CUSTOMER¿S BIOMED. THE DEVICES PASSED ALL PREVENTATIVE MAINTENANCE CHECKS, AND BIOMED COULD NOT DUPLICATE THE ERROR IN A TEST WITH SETTINGS USED IN THE INCIDENT.

    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. ADMITTING DIAGNOSIS- GUN SHOT WOUND, BRAIN HERNIATION. ALTHOUGH REQUESTED, PATIENT RACE AND ETHNICITY WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT ON (B)(6) 2021, A PHENYLEPHRINE OVERINFUSION ALLEGEDLY OCCURRED WHEN A NEW BAG OF PHENYLEPHRINE WAS FOUND NEARLY EMPTY. THE PATIENT WAS ADMITTED FOR A GUNSHOT WOUND AND DIAGNOSED WITH BRAIN HERNIATION AND BRAIN DEATH, AND WAS BEING TRANSITIONED FROM A CONTINUOUS LEVOPHED (NOREPINEPHRINE) INFUSION TO A NEO-SYNEPHRINE (PHENYLEPHRINE) INFUSION. THE INFUSIONS WERE TITRATABLE FOR A BLOOD PRESSURE GOAL OF MEAN ARTERIAL PRESSURE (MAP) GREATER THAN 65. THE BAG OF PHENYLEPHRINE (CONCENTRATION 30MG IN 100ML) WAS STARTED AT 21:58 USING THE CRITICAL CARE ADULT PROFILE FOR A DOSE OF 20MCG/MIN (RATE OF 4ML/H), HOWEVER IT WAS ALLEGEDLY DISCOVERED THAT THE BAG HAD COMPLETELY INFUSED INTO THE PATIENT WITHIN THE FIRST FIVE MINUTES AFTER STARTING PHENYLEPHRINE. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AT 22:05 WHEN THE PATIENT'S HEART RATE JUMPED TO THE 140S AND SYSTOLIC BLOOD PRESSURE UP TO 160S, SO THE NURSE TITRATED THE NOREPINEPHRINE RATE DOWN. AT 22:10 THE PATIENT'S BLOOD PRESSURE INCREASED TO 219/143 WITH A HEART RATE OF 151, AND BOTH THE PHENYLEPHRINE AND NOREPINEPHRINE INFUSIONS WERE STOPPED, AND THE PATIENT WAS MONITORED. UPON STOPPING THESE MEDICATIONS, THE NURSE NOTICED THE NEW BAG OF PHENYLEPHRINE WAS NEARLY EMPTIED. WHEN THE NURSE ASSESSED THE PATIENT, IT WAS DISCOVERED THAT HE HAD COMPLETELY HERNIATED. UPON FURTHER CLARIFICATION BY THE NURSING SUPERVISOR, THE PATIENT WAS ALREADY DECLARED BRAIN DEAD IN THE MORNING PRIOR TO THE EVENT ON (B)(6) 2021 AT 0730, BUT REPORTEDLY COMPLETED HERNIATION DUE TO THE RAPID INCREASE IN BLOOD PRESSURE BECAUSE OF THE EVENT. THE PRIMARY CAUSE OF BRAIN DEATH WAS HERNIATION DUE TO A GUNSHOT WOUND. AN AUTOPSY WAS NOT PERFORMED, AS THE PATIENT WAS AN ORGAN DONOR. THE EVENT DID NOT IMPEDE OR AFFECT THE ORGAN DONATION PROCESS. THE PRIMARY NURSE AND GOH (GIFT OF HOPE, ORGAN DONATION) NURSE DID A DOUBLE CHECK ON THE PUMP SETTINGS, AND VERIFIED THAT THE SETTINGS WERE CORRECT. THE TUBING SET WAS DISCARDED, BUT THE PCU PUMP AND LARGE VOLUME PUMP MODULE WERE SEQUESTERED AND TESTED BY THE CUSTOMER¿S BIOMED. THE DEVICES PASSED ALL PREVENTATIVE MAINTENANCE CHECKS, AND BIOMED COULD NOT DUPLICATE THE ERROR IN A TEST WITH SETTINGS USED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507815 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening 8015| PRI TUBING