BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER 1550 SPS

    MDR report key: 67059 · Received December 31, 1996

    Report

    Report Number
    67059
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    May 14, 1996
    Report Date
    June 28, 1996
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED FOR DIALYSIS TREATMENT WITH NO COMPLIANTS. BP 128/64, P 74, T 967 AND WEIGHT 2.8 KG. DIALYSIS WAS INITIATED AT 7:56 AM WITHOUT DIFFICULTY. BP 137/71, P73, BFR 300, DFR 700 ANF UFR 1.28. PT REPORTED NO COMPLAINTS DURING TREATMENT BP 10/57-145/70. AT 10:35 AM PT SCREAMED LOUDLY AND BEGAN TO SHAKE. SHE BECAME UNRESPONSIVE TO VERBAL STIMULI AND APPEARED TO BE HAVING A GRAND MAL SEIZURE BP 167/?. DIALYSIS WAS TERMINATED AND BLOOD WAS RETURNED. THE PT WAS SENT TO THE HOSP AND ADMITTED FOR FURTHER EVAL. IN THE ER THE PT CONTINUED TO SEIZE AND WAS NOTED TO HAVE A RUN OF VENTRICULAR TACHYCARDIA WHICH REVERTED SPONTANEOUSLY. THE SEIZURE ALSO ENDED SPONTANEOUSLY AND THE PT WAS AWAKE AND ABLE TO SPEAK. THE PT'S INITIAL LAB SHOWED NA 128, K4.3, CO211, CL 90, CA 11.1, LD 975, WBC 16.3, HGL 11.2, HCT 32.7. THE DIALYSIS MACHINE WAS REMOVED FROM SERVICE AND TEMPERARURE AND BLOOD DURING OCCLUSION WERE CHECKED AND FOUND TO BE SATISFACTORY. ON 5/20/96, THE MACHINE WAS REMOVED FROM SERVICE BEACUSE PT COMPLAINED OF SHORTNESS OF BREATH AND FEELING SICK. SHE WAS SENT TO THE HOSP. SYMPTOMS WERE FOUND TO BE RELATED TO AN ABSCESS AT HER PACEMAKER SITE. THE MACHINE WAS EVALUATED BY THE CO TECHNICAL SERVICE AND FOUND TO NOT BE CALIBRATED PER IT'S SPECIFICATIONS. THE ACTUAL CONDUCTIVITY WAS LOW AND THE 3 PRINTED CIRCUIT BOARDS WERE INCOMPATIBLE WITH THE DEVICE MFR, INSTALLED CONFIGURATION SOFTWARE AND THE VOLUMETRIC CALIBRATIONS OF THE PROPORTIONING PUMPS WERE SET INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER 1550 SPS HEMODIALYSIS MACHINE FKP BAXTER HEALTHCARE 1550 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O NMC BLOODLINES 037221/037303| NMC BICARB & ACID CONCENTRATE 9000 SERIES| FRESENIUS F. 80B DIALYZER