FDA Adverse Event Death Summary report: N

FLEXIFLOW III

MDR report key: 5560 · Received March 26, 1993

Report

Report Number
5560
Event Type
Death
Date Received
March 26, 1993
Date of Event
February 22, 1993
Report Date
February 25, 1993
Manufacturer
ROSS LABORATORIES
Product Code
FPD
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

THE PATIENT WAS A 87 YEAR OLD MALE, ADMITTED ON 2/22/93 WHO HAD BRAIN CANCER COLON CANCER, R/O SEPSIS, PNEUMONIA. ON 2/22/93, AT APPROXIMATELY 2200 1/2 STRENGTH ISOCAL FEEDING STARTED AT 50CC/HR VIA N/G TUBE. APPROX. 30 MINUTES LATER, IT WAS NOTED THAT 400CC INFUSED. MD CALLED. PATIENT LATER EXPIRED ON 2/23/93 AT 9:40 PM. THE CAUSE OF DEATH LISTED WAS CARDIOPULMONARY ARREST, SECONDARY TO PNEUMONIA, SEPSIS. THE PATIENT WAS A DO NOT RESUSCIATEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-DEC-92. 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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FLEXIFLOW III ENTERAL NUTRITION PUMP FPD ROSS LABORATORIES FLEXIFLOW III N/A

Patients

Seq Age Sex Outcome Treatment
1 87 YR Death