BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2665051 · Received July 17, 2012

    Report

    Report Number
    1722139-2012-00823
    Event Type
    Death
    Date Received
    July 17, 2012
    Date of Event
    May 18, 2012
    Report Date
    June 18, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS INVESTIGATED BY DISTRIBUTOR AS FOLLOWS: ANALYSIS OF THE PUMP HISTORY LOG SHOWS THAT THE PUMP PERFORMED AS PROGRAMMED BY THE USER. A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE PUMP, IN ACCORDANCE WITH THE NUTRICIA FULL SERVICE TEST PROCEDURE, WAS CARRIED OUT. THE DELIVERED VOLUMES FOR EACH TEST WERE WITHIN THE REQUIRED SPECIFICATION. THERE WERE NO VISUAL FAULTS EVIDENT AND ALL FUNCTION TESTS PERFORMED WITHIN THE MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 1

    DISTRIBUTOR ALLEGED THEY RECEIVED A COMPLAINT REGARDING A (B)(6) WOMAN WHO HAD BEEN DIAGNOSED WITH MOTOR NEURON DISEASE IN (B)(6) 2010. THE DISEASE CAUSED HER TO HAVE SEVERE LIMITATION OF MOVEMENT AND WAS FED VIA A PEG TUBE BECAUSE DIFFICULTY SWALLOWING. SHE WAS ADMITTED TO (B)(6) WITH ASPIRATION PNEUMONIA, WHICH DEVELOPED A RESULT OF VOMITING, BECAUSE A DISTRICT NURSE HAD INADVERTENTLY INCREASED THE PEG FEEDING RATE. HER MEDICATION AT THE TIME OF ADMISSION WERE FLUOXETINE, DOMPERIDONE, OMEPRAZOLE, PARACETAMOL, RILUZOLE AND GLYCOPYRRONIUM. FOLLOWING ADMISSION TO (B)(6), SHE WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WAS IMPROVEMENT AND SHE WAS TRANSFERRED TO THE RESPIRATORY WARD ON (B)(6) 2012. SHE WAS SWITCHED TO ORAL ANTIBIOTICS ON (B)(6) 2012. ON (B)(6) 2012, SHE HAD DETERIORATED AND SHOWED AN INCREASED HEART AND RESPIRATORY RATE. ARTERIAL BLOOD GASSES SHOWED A COMPENSATED RESPIRATORY ACIDOSIS. IV ANTIBIOTICS WERE RECOMMENCED AND SHE WAS ALSO COMMENCED ON HEPARIN IN CASE SHE HAD DEVELOPED A PULMONARY EMBOLUS. HOWEVER HER CONDITION DETERIORATED RAPIDLY AND SHE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death RILUZOLE| INTRAVENOUS ANTIBIOTICS| DOMPERIDONE| FLUOXETINE| OMEPRAZOLE| PARACETAMOL| ORAL ANTIBIOTICS| GLYCOPYRRONIUM