BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMS GRASEBY

    MDR report key: 332468 · Received May 9, 2001

    Report

    Report Number
    1122814-2001-00001
    Event Type
    Other
    Date Received
    May 9, 2001
    Date of Event
    January 16, 2001
    Report Date
    February 22, 2001
    Manufacturer
    MARCAL MEDICAL/IMPORTER-DISTRIBUTOR, SIMS GRASEBY LIMITED
    Product Code
    FRN
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SYRINGE PUMP INFUSED A CARDIAC STRESS AGENT 30 SECONDS TOO FAST DURING A CARDIAC STRESS TEST. MARCAL'S BIOMEDICAL SERVICES TECHNICIAN TROUBLE SHOT OVER THE PHONE WITH HOSPITAL BIOMEDICAL SERVICE TECHNICIAN AND DETERMINED THAT THERE WAS NO DEATH OR INJURY TO THE PT INVOLVED. ALSO DETERMINED THAT THE CUSTOMER WAS USING A 30CC SYRINGE. HOWEVER, THE SYRINGE SIZE SENSOR DISPLAY ON THE PUMP WAS INDICATING THAT A 20CC SYRINGE WAS BEING USED. THE PUMP WOULD INDEED INFUSE CORRECTLY IF THE SYRINGE SIZE DISPLAY READ DIFFERENTLY FROM THE ACTUAL SIZE OF THE SYRINGE BEING USED. THE OPERATIONS MANUAL CLEARLY PROHIBITS USING THE PUMP IF THE SYRINGE SIZE SENSOR DISPLAY READING DOES NOT AGREE WITH THE SYRINGE SIZE BEING USED. THIS WAS AN OBVIOUS OPERATOR ERROR AND COULD HAVE BEEN PREVENTED IF THE USER HAD READ THE DISPLAY BEFORE USING THE PUMP. MFR REQUESTED THE PUMP BE RETURNED TO MARCAL MEDICAL FOR REPAIR AND CALIBRATION. AN INCIDENT REPORT WAS FILLED OUT TO BE FOLLOWED UP ON WHEN INVESTIGATION COMPLETED. FOLLOW-UP ACTIONS TAKEN: CALIBRATED THE SYRINGE SIZE SENSOR. VERIFIED PROPER OPERATION BY PERFORMING PREVENTIVE MAINTENANCE PER MFR'S SPECIFICATIONS. INSERVICED THE USER REGARDING THE IMPORTANCE OF MAKING SURE DISPLAY OF THE PUMP MATCHES THE ACTUAL SIZE AND MANUFACTURE TYPE OF THE SYRINGE BEFORE BEGINNING A PROCEDURE. FINAL REVIEW BY MARCAL MEDICAL PRESIDENT: A RE-CALIBRATION OF THE SYRINGE SIZE SENSOR SOLVED THIS PROBLEM. THE USER SHOULD NOT HAVE USED THE PUMP WITH THE SYRINGE SIZE SENSOR DISPLAY CLEARLY SHOWING A DIFFERENT SIZE SYRINGE THAN ACTUALLY USED. THE PUMP OPERATORS MANUAL PROHIBITS USING THE PUMP IF THE SYRINGE SIZE SENSOR DISPLAY DOES NOT AGREE WITH THE SYRINGE BEING USED. INVESTIGATION PROCEDURE: UNIT REPORTED AS RUNNING AT AN INCORRECT RATE DUE TO A MIDREADING OF THE LOADED SYRINGE. THE MARCAL ENGINEER HAD CONFIRMED WITH THE CUSTOMER THAT A 30CC SYRINGE WAS FITTED DURING THIS INFUSION, HOWEVER THE PUMP HAD RECOGNIZED THE FITTED SYRINGE AS A 20CC. IT IS QUITE CLEAR THAT IF THIS WERE THE CASE THE PUMP WOULD HAVE OVER-INFUSED. UNFORTUNATELY MFR DOES NOT HAVE SYRINGE THAT WAS USED TO ENABLE THEM TO CORRECTLY VALIDATE THIS OBSERVATION THERE IS ALSO NO MENTION OF THE SYRINGE BRAND. THE FOLLOWING INFO IS BASED ON BD SYRINGES: PUMP FITTED WITH A 30ML SYRINGE BUT INDICATING A 20ML, THE PUMP WOULD OVER-DELIVER BY 29.24%. PUMP FITTED WITH A 20ML SYRINGE BUT INDICATING A 30ML, THE PUMP WOULD UNDER-DELIVER BY 22.626%. AS THE PUMP DOES NOT CONTAIN A HISTORY EVENT LOG MFR IS UNABLE TO CONFIRM WHETHER THIS WAS AN UNDER OR OVER-INFUSION. CONCLUSION: UNABLE TO CONFIRM THE REPORT OF OVER-DELIVERY OF THE PUMP. RECOMMENDATIONS/CORRECTIVE ACTION: REPLACE GRUB SCREW AND CALIBRATE SIZE SENSOR ARM, CARRY OUT FULL SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21272 SIMS GRASEBY SYRINGE PUMP FRN MARCAL MEDICAL/IMPORTER-DISTRIBUTOR, SIMS GRASEBY LIMITED 3400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other PERSANTINE UNK.