BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2473698 · Received March 1, 2012

    Report

    Report Number
    2531779-2012-01671
    Event Type
    Death
    Date Received
    March 1, 2012
    Date of Event
    May 12, 2011
    Report Date
    January 31, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ASSET SERIAL NUMBER: (B)(4). (B)(6). THE PUMP, CARTRIDGES, AND INFUSION SETS WERE RETURNED ON 01/25/2012 FOR INVESTIGATION. THE INFUSION SETS WERE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION AND REPORTING PURPOSES. THE FOLLOWING FINDINGS ARE BASED ON THE CARTRIDGE INVESTIGATIONS COMPLETED ON 01/31/2012: THERE WERE 31 CARTRIDGES RETURNED TO ANIMAS; 1 WAS FOUND IN AN OPEN PACKAGE AND THE OTHERS WERE IN SEALED PACKAGES. ALL CARTRIDGES WERE TESTED AND PASSED VISUAL INSPECTION WITH NO DAMAGE NOTED TO THE LUER CONNECTION OR THE O-RINGS. FILL TESTS, LEAK TESTS, AND FORCE TESTS WERE PERFORMED WITH NO FAILURES OBSERVED. THE FOLLOWING FINDINGS ARE BASED ON THE PUMP INVESTIGATION COMPLETED ON 01/30/2012: THE PUMP WAS SUBJECTED TO A 29-HOUR FLOW TEST AND WAS FOUND TO BE DELIVERING ACCURATELY. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE PROGRAMMED BASAL RATES. TOTAL DAILY DOSE (TDD) WAS REVIEWED FOR THE DATES (B)(4) 2011 AND (B)(4) 2011. THE VALUES RANGED BETWEEN 48.2 UNITS AND 92.2 UNITS; THE TDD ON (B)(4) 2011 WAS 69.5 UNITS. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN THE BLACK BOX OR PUMP HISTORY. PRIOR TO THE PATIENT'S DEATH, BOLUS DELIVERY WAS CONSISTENT DURING THE TWO WEEK REVIEW PERIOD. THE LAST BOLUS WAS DELIVERED AT 8:11PM ON (B)(4) 2011. ALL BOLUSES WERE FULLY DELIVERED AS PROGRAMMED; THERE WERE NO CANCELLED OR UNDELIVERED BOLUSES. IN SUMMARY, NO EVIDENCE OF INSULIN DELIVERY DEFECTS, MALFUNCTIONS, OR MISUSE WAS DETECTED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S PUMP, CARTRIDGES, AND INFUSION SETS WERE RECEIVED BY ANIMAS FOR INVESTIGATION. THESE PRODUCTS WERE SAID TO HAVE BEEN USED AT THE TIME OF THE PATIENT'S DEATH. THE REPORTER STATED THAT THEY WERE GIVEN TO THE CORONER SHORTLY AFTER THE PATIENT'S DEATH ON (B)(6) 2011 AND THAT THE CORONER WISHED THE PRODUCTS BE RETURNED TO ANIMAS. THE CORONER, FAMILY MEMBERS, AND OTHER HEALTH CARE PROFESSIONALS HAVE BEEN UNWILLING OR UNABLE TO PROVIDE ADDITIONAL COMMENTS. THERE WAS NO ALLEGATION THAT THE PUMP OR CARTRIDGES CONTRIBUTED TO THE PATIENT'S DEMISE. IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL ON (B)(6) 2011 AT 3:15AM AND DIED LATER THAT MORNING AT 10:05AM. THE CAUSE OF DEATH WAS REPORTED TO BE A CONSEQUENCE OF DIABETIC KETOACIDOSIS SECONDARY TO A KINKED CANNULA. AT THE TIME OF THE INITIAL CONTACT ((B)(6) 2011), THE REPORTER'S COMPLAINT WAS FORWARDED TO THE MANUFACTURER OF THE INFUSION SET FOR REPORTING PURPOSES. THERE WAS NO ALLEGATION BY THE PATIENT'S HEALTH CARE PROVIDERS OR FAMILY MEMBERS THAT ANY ANIMAS MANUFACTURED PRODUCT CONTRIBUTED TO THE DEATH AT THE TIME OF THE ORIGINAL CONTACT. ALTHOUGH THERE IS NO CLAIM BY THE CORONER, HEALTH CARE PROFESSIONALS, OR FAMILY MEMBERS THAT THE PUMP OR CARTRIDGES WERE ASSOCIATED WITH THE PATIENT'S DEATH, THIS COMPLAINT IS BEING REPORTED BECAUSE ANIMAS MANUFACTURED PRODUCTS THAT WERE IN USE AT THE TIME OF THE PATIENT'S DEATH WERE RETURNED TO ANIMAS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death