FDA Adverse Event Summary report: N

PERMCATH DUAL LUMEN DIALYSIS CATHETER

MDR report key: 33974 · Received July 8, 1996

Report

Report Number
MW1009456
Date Received
July 8, 1996
Date of Event
June 22, 1996
Report Date
July 4, 1996
Manufacturer
QUINTON INSTRUMENT CO.
Product Code
LFJ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A 24-YR-OLD BLACK FEMALE ADMITTED TO THE HOSP ON 6/19/96 WITH DIAGNOSIS OF CEREBRAL HEMORRHAGE; ESRD ON MAINTENANCE HEMODIALYSIS. SHE REQUIRED "NO HEPARIN" DIALYSIS BECAUSE OF HER NEUROLOGICAL STATUS. DURING HEMODIALYSIS ON 6/22/96, THE NURSE PROVIDING THE DIALYSIS TREATMENT HAD EXPERIENCED PROBLEMS WITH BLOOD CLOTTING, NECESSITATING CHANGING OF THE AV BLOOD LINES AND DIALYZER. FINALLY WITH INCREASING VENOUS PRESSURES SUDDENLY RISING AGAIN ON THE DIALYSIS MACHINE THE DUAL LUMEN CATHETER WAS CHECKED TO VERIFY PATENCY OF THE VASCULAR ACCESS. BLOOD WAS ASPIRATED AND DISCARDED FROM THE CATHETER PORTS WITH NO CLOTS NOTED. WHILE ASPIRATING AND RE-INSTILLING BLOOD TO VERIFY SMOOTH INFLOW, THE CATHETER RUPTURED AT THE SITE OF THE JOINING OF THE TWO LUMENS. A FINE MIST OF BLOOD SPRAYED APPROX SIX FEET AROUND THE PT. BLOOD LOSS WAS MINIMAL, BUT AN AIR LEAK WAS NOTED WHEN AGAIN ASPIRATING FROM THE PORTS. THE CATHETER WAS CLAMPED BELOW THE TEAR TO PREVENT QUESTIONABLE POTENTIAL AIR EMBOLISM AND ALSO DETER A SOURCE OF CONTAMINATION/INFECTION FOR THE PT. A SURGEON WAS NOTIFIED TO REMOVE THE CATHETER ASAP PER ORDER OF THE NEPHROLOGIST. THE NEPHROLOGIST WAS AT THE PT'S BEDSIDE DURING THIS INCIDENT AND STATED THE NURSE FORCEFULLY INJECTED INTO THE PORT CAUSING THE RUPTURE. THE NURSE DENIES THIS RPTR WAS IN THE UNIT BUT DID NOT WITNESS THIS OCCURRENCE. THE CO WAS CONTACTED TO INFORM AND ASCERTAIN IF OTHER CATHETER RUPTURES HAVE BEEN REPORTED AND ALSO TO PROVIDE A RESOURCE IN DETERMINING IF EXCESSIVE FORCE HAD BEEN UTILIZED. ALTHOUGH MULTIPLE PROCEDURES WERE REQUIRED BY THE SURGEON, RADIOLOGIST, AND NEPHROLOGIST TO PLACE ANOTHER VASCULAR ACCESS INTO THE PT, SUCCESSFUL CATHETER PLACEMENT WAS PROVIDED ON 6/25/96. PT IS PRESENTLY DIALYZING IN UNIT WITHOUT DIFFICULTY. LUCKILY NO ADVERSE PT RESPONSE RESULTED FROM THIS INCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PERMCATH DUAL LUMEN DIALYSIS CATHETER DUAL LUMEN DIALYSIS CATHETER LFJ QUINTON INSTRUMENT CO.

Patients

Seq Age Sex Outcome Treatment
1 24 YR