FDA Adverse Event Death Summary report: N

SWAN GANZ CATHETER-THERMODILUTION PACEPORT

MDR report key: 8820 · Received July 29, 1994

Report

Report Number
8820
Event Type
Death
Date Received
July 29, 1994
Date of Event
April 27, 1994
Report Date
June 20, 1994
Manufacturer
BAXTER EDWARDS CRITICAL CARE DIVISION
Product Code
DYG
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
PA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

WHILE PLACING SWAN GANZ WITH PATIENT FLAT IN BED, THE PATIENT DEVELOPED A COUGH AND UPPER AIRWAY CONGESTION. THE PHYSICIAN STOPPED ADVANCING THE SWAN GANZ AND DRAPES WERE REMOVED FROM PATIENT'S FACE AND HEAD. THE PATIENT WAS SUCTIONED FOR LARGE AMOUNTS OF BRIGHT RED BLOOD, BUT CONTINUED TO HEMORRHAGE ND SUBSEQUENTLY WENT INTO RESPIRATORY ARREST. SHE WAS A "LIMITED CODE". THE PATIENT EXPIRED. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL A WEEK EARLIER WITH A SEVERE STROKE. SHE WAS ON HEPARIN AT THE TIME OF THE INCIDENT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT 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.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SWAN GANZ CATHETER-THERMODILUTION PACEPORT DYG BAXTER EDWARDS CRITICAL CARE DIVISION 93A-931H 7.5F 2W19A 4500A

Patients

Seq Age Sex Outcome Treatment
1 86 YR Death