FDA Adverse Event Death Summary report: N

ARROW INTERNATIONAL, INC.

MDR report key: 2068 · Received January 5, 1993

Report

Report Number
2068
Event Type
Death
Date Received
January 5, 1993
Date of Event
October 20, 1992
Report Date
December 3, 1992
Manufacturer
ARROW INTERNATIONAL, INC.
Product Code
GBP
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

RECEIVED ORDER FROM PHYSICIAN TO REMOVE TRIPLE LUMEN CATHETER FROM RIGHT JUGULAR. WITH PATIENT SITTING ON SIDE OF BED, CATHETER WAS CHECKED AND DETERMINED TO BE INTACT; ALL PORTS WERE CLAMPED. THE CATHETER HAD BEEN HELD SECURE BY TWO SUTURES, WHICH WERE RELEASED AND AREA WAS CLEANSED WITH BETADINE. A 4X4 DRESSING WAS APPLIED AND TAPED SECURELY. SOON AFTER PATIENT BEGAN EATING HIS MEAL, BEGAN COUGHING, BECAME SHORT OF BREATH AND PROGRESSIVELY WENT INTO CARDIAC ARREST. HE WAS IMMEDIATELY CODED WITH ALL ACLS MEASURES APPLIED WITHOUT SUCCESS AND WAS PRONOUNCED DEAD AFTER BEING RESUSCITATED FOR OVER AN HOURDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, OTHER, INHERENT RISK OF PROCEDURE, UNANTICIPATED. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, USER EDUCATION PROVIDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ARROW INTERNATIONAL, INC. ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHERIZATION KIT GBP ARROW INTERNATIONAL, INC. UNKNOWN UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 45 YR Death