FDA Adverse Event Death Summary report: N

MOSS GASTROSTOMY TUBE

MDR report key: 560057 · Received December 14, 2004

Report

Report Number
560057
Event Type
Death
Date Received
December 14, 2004
Date of Event
September 26, 2004
Report Date
December 13, 2004
Manufacturer
MOSS TUBE INC.
Product Code
KNT
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
VA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE PT CAME TO FACILITY FOR SURGICAL EXCISION OF ADENOCARCINOMA OF PANCREAS. A MOSS GASTROSTOMY TUBE (SHOWN BELOW) WAS INSERTED NEAR THE CLOSE OF THE PROCEDURE. THE DISCHARGE SUMMARY STATES THAT THE MOSS TUBE BALLOON (SEEN JUST INSIDE THE GASTRIC WALL) WAS INFLATED WITH 10 CC OF WATER DURING THE PROCEDURE, POST-OPERATIVE ORDERS SAID THE "FEEDING" TUBE WAS TO BE IRRIGATED WITH 10CC OF WATER EVERY SIX HOURS. INITIALLY, RECOVERY WAS AS EXPECTED, BUT ON THE SIXTH POST-OPERATIVE DAY THE PT BECAME INCREASINGLY SHORT OF BREATH. PT WAS TRANSFERRED TO THE ICU AND THERE WASCONCERN THAT THEIR OVERALL PICTURE REFLECTED SEPSIS. SURGICAL RE-EXPLORATION WAS CONDUCTED ON POST-OPERATIVE DAY NINE. THIS REVEALED EROSION OF THE GASTRIC WALL ADJACENT TO THE MOSS TUBE BALLOON. THE BALOON CONTAINED 40 CC OF CLEAR FLUID. THE RECORD DOES NOT INDICATE HOW THE ADDITIONAL 30 CC OF FLUID GOT INTO THE BALLOON INFLATION POST. ONLY THE "FEEDING" PORT WAS TO BE IRRIGATED WITH WATER AFTER THE INITIAL SURGERY. THE WORDS "FEEDING" AND "SUCTION" APPEAR ON TWO OF THE MOSS TUBE PORTS, BUT IN THE SAME COLOR AND MATERIAL AS THE PORTS THEMSELVES, WHILE THE THIRD PORT, THE BALLOON INFLATION PORT, IS RED WITH "20CCH20" WRITTEN ON IT. THE PT DID NOT DO WELL AFTER RE-EXPLORATION AND HAD CONTINUED ELEVATION OF PT BLOOD SUGAR, DECREASE OF THEIR BLOOD PRESSURE, AND PERSISTENT HYPOXEMIA. THE PT BECAME ASYSTOLE, WAS CODED AND DIED EARLY ON POST-OPERATIVE DAY ELEVEN. THERE WAS NO AUTOPSY. TUMOR PATHOLOGY REVEALED THAT PT PANCREATIC CANCER WAS A STAGE IIB ADENOCARCINOMA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MOSS GASTROSTOMY TUBE FEEDING & DECOMPRESSION TUBE KNT MOSS TUBE INC. UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 65 YR Death MEDICATIONS.| FOLEY CATHETER, J-P DRAINS, NG TUBE, VARIOUS