BEUDAMED
    FDA Adverse Event Death Summary report: N

    SINGLE TUBE HOSE, 90496/91496/91

    MDR report key: 7984174 · Received October 18, 2018

    Report

    Report Number
    MW5080683
    Event Type
    Death
    Date Received
    October 18, 2018
    Date of Event
    September 13, 2018
    Report Date
    October 18, 2018
    Manufacturer
    SPACELABS HEALTHCARE, INC.
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED (B)(6) AT 02:13 FOR EARLY SYSTEM SEPSIS AND ACUTE RENAL FAILURE (ANION GAP 26, BUN 27, LACTATE 10), VITALS ON ADMISSION 102/59, HR 127, RR 24, RECTAL TEMP 37. PROVIDE ADMITTED PT TO ICU ROOM 209 AND ANTIBIOTICS CEFEPIME AND VANCOMYCIN WERE STARTED. VITALS WERE CONTINUED TO BE TAKEN DURING PT'S STAY; HOWEVER, ICU SPACELAB'S MONITOR RESULTS APPEARED TO BE ERRATIC AND INACCURATE. BLOOD PRESSURES TAKEN WOULD READ 84/35 AND THEN FEW MINS LATER 132/50. O2 SAT METER WOULD READ ONLY INTERMITTENTLY. APPROX 13:30 PT'S BLOOD PRESSURE APPEARED TO BE LOW BUT CONTINUED TO BE NOT READING CORRECTLY AT 13:40 BP AT 87/67 THEN JUMPED TO 102/93. VITALS WERE BEING TAKEN EVERY 5 MINS AND AT 13:55 BP RESULTS WERE 45/31 AND JUMPED UP AGAIN TO 122/95. O2 SAT ALSO CONTINUED TO BE READING INTERMITTENTLY AND AT 14:10 FAILED TO READ O2 SAT RESULTS ALTOGETHER. (AT ONE POINT THE O2 SAT METER WAS COMPLETELY OFF THE PT AND THEN MONITOR SCREEN INDICATED O2 SAT WAS 88% AND DISPLAYED A RESPIRATORY WAVE FORM.) PRIMARY NURSE STARTED TAKING MANUAL VITALS IN ADDITION TO MONITOR AS PT DECLINED QUICKLY. RAPID RESPONSE WAS CALLED AND EVENTUALLY PT WENT INTO PEA AND WAS FULLY CODED. MONITORING PT PRIOR AND DURING CODE WAS EXTREMELY DIFFICULT DUE TO THE UNRELIABLE RESULTS. VITAL SIGN TRENDS, AS PT DECLINED, WERE ALSO EXTREMELY DIFFICULT TO DETERMINE AS RESULTS WERE SO INCONSISTENT. PT EXPIRED SHORTLY AFTER 15:00. MSRN; ADDITIONAL INFO: PT ADMITTED WITH SEPSIS AND HAS HISTORY OF SUBSTANCE ABUSE. PT ADMITTED TO ICU. PT WAS GIVEN ANTIBIOTICS AND HAD CENTRAL LINE PLACED AND WAS INTUBATED DURING ADMISSION PRIOR TO CARDIAC ARREST. PT ARRESTED INTO PEA RHYTHM AND WAS CODED FOR APPROX AN HOUR WITH APPROPRIATE MEASURES PROVIDED IN ATTEMPT TO REVIVE PT. PRIOR TO FULL CODE, VITALS WERE TAKEN MANUALLY WITH ASSISTANCE OF HAND HELD DEVICES SUCH AS DOPPLER. PT WAS ALSO TRANSFERRED TO LIFEPAK CARDIAC RESUSCITATOR FOR CARDIAC MONITORING AND PACING ATTEMPT. MEDICAL EQUIPMENT: THE TUBE CONNECTING THE SPACELABS MONITOR AND BP CUFF WAS CRACKED WHICH CAUSED IT TO LEAK AND PROVIDE INACCURATE READINGS. ALL SPACELABS MONITORS WITHIN THE DEPARTMENT WERE FUNCTIONALLY TESTED BY BIOMED TECH. ALL MONITORING DEVICES PASSED FUNCTIONAL TEST. THE TUBE IN QUESTION WAS DISCARDED AFTER THE INCIDENT BY MEDICAL STAFF. CLINICAL ENGINEERING WAS UNABLE TO FURTHER INVESTIGATE THE CAUSE OF FAILURE. ADD'L INFO PART # 714-0018-00, SPACELABS HEALTHCARE DESCRIPTION: SINGLE TUBE HOSE, 90496/91496/91330, SIZE: ADULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817390 SINGLE TUBE HOSE, 90496/91496/91 COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION DXG SPACELABS HEALTHCARE, INC. 90496/91496/91330

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death