BEUDAMED
    FDA Adverse Event Injury Summary report: N

    965 MICRO VOLUMETRIC INFUSION PUMP

    MDR report key: 3526 · Received July 29, 1992

    Report

    Report Number
    3526
    Event Type
    Injury
    Date Received
    July 29, 1992
    Date of Event
    November 28, 1991
    Report Date
    December 10, 1991
    Manufacturer
    IMED CORPORATION, SAN DIEGO, CA 92131
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    IV INFUSION OF HYPERALINENTATION SOLUTION CONTAINING CALCIUM GLUCOMATE. IV INFUSING IN THE RIGHT ANTECUBITAL SPACE THROUGH 24G., 1.6 CM BAXTER QUICK-CATH VIA IMED MODEL 965 PUMP. IV SITE CHECKED EVERY TWO HOURS. AT 0130 DISCOVERED TO HAVE INFILTRATED. IV DC'D. PHYSICIAN NOTIFIED. O,ED RE,PVED FRP, SERVOCE/ EXCPROATED ;ESOPM DEVEOPED RIGHT ELBOW; SURGICAL DEBRIDEMENT OF AREA DONE. IMED PUMP EVALUATED AND FOUND TO OPERATE ACCORDING TO SPECIFICATIONS. IV CATHETER SET WAS DISCARDED PRIOR TO EVALUATION.OTHERD DEVICES INVOLVED: QUICK-CATHGENERIC NAME: INTRAVASCULAR TEFLON CATHETERMANUFACTURER NAME: BAXTER HEALTHCARE CORPORATIONEVENT DESCRIPTION: IV INFUSION OF HYPERALINENTATION SOLUTION CONTAINING CALCIUM GLUCOMATE. IV INFUSING IN THE RIGHT ANTECUBITAL SPACE THROUGH 24G., 1.6 CM BAXTER QUICK-CATH VIA IMED MODEL 965 PUMP. IV SITE CHEKED EVERY TWO HOURS. AT 0130 DISCOVERED TO HAVE INFILTRATED. IV DC'D. PHYSICIAN NOTIFIED. IMED REMOVED FROM SERVICE. EXCORIATED LESION DEVELOPED RIGHT ELBOW; SURGICAL DEBRIDEMENT OF AREA DONE. IMED PUMP EVALUATED AND FOUND TO OPERATE ACCORDING TO SPEFCIFICATIONS. IV CATHETER SET WAS DISCARDED PRIOR TO EVALUATION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-OCT-91. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, INHERENT RISK OF PROCEDURE, RELATED TO ANOTHER DRUG/DEVICE. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 965 MICRO VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN IMED CORPORATION, SAN DIEGO, CA 92131 MODEL 965 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention