FDA Adverse Event Death Summary report: N

HARVARD PCA INFUSER

MDR report key: 1309 · Received September 4, 1992

Report

Report Number: 1309
Event Type: Death
Date Received: September 4, 1992
Date of Event: August 21, 1992
Report Date: September 1, 1992
Manufacturer: C.R. BARD, INC.
Product Code: MEA
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

ON AUGUST 21, 1992, THE PATIENT WAS RECEIVING INFUSION OF FENTANYL FOR PAIN MANAGEMENT VIA HARVARD PCA INFUSER, WHEN PATIENT SUFFERED CARDIAC ARREST. FULL CARDIAC-PULMONARY RESUSCIATION PROCEDURES WERE IMPLEMENTED. HOWEVER, THE PATIENT WAS UNABLE TO BE RESUSCIATED AND EXPIRED. RESULTS IN INVESTIGATION ARE PENDING. OTHER DEVICES IN USE AT THE TIME OF THE EVENT WERE: INFUSION CONTROLLER MANUFACTURER BY IVAC - AQUATIC HEAT PAD - MANUFACTURED BY BAXTER HEALTHCARE CORPORATION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-FEB-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: NONE OR UNKNOWN. RESULTS OF EVALUATION: 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	HARVARD PCA INFUSER	PATIENT CONTROLLED ANALGESIA MACHINE	MEA	C.R. BARD, INC.	6464-001	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	25 YR		Death