FDA Adverse Event Summary report: N

DUAL INFUSION PUMP

MDR report key: 4462 · Received July 3, 1992

Report

Report Number
4462
Date Received
July 3, 1992
Manufacturer
AVI INC
Product Code
FRN
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

2700 ML BAG OF TPN HUNG. RATE SET AT 100 ML; 2100 ML INFUSED IN APPROXIMATELY TWO HOURS RATHER THAN TWENTY FOUR HOURS. PATIENT HAD SEIZURES AND WAS TRANSFERRED TO ICU. INVESTIGATION OF CAUSE INCONCLUSIVE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DUAL INFUSION PUMP FRN AVI INC 840

Patients

Seq Age Sex Outcome Treatment
1 Invalid Data