FDA Adverse Event Death Summary report: N

SAFE DWEL PLUS

MDR report key: 15884 · Received July 21, 1994

Report

Report Number
15884
Event Type
Death
Date Received
July 21, 1994
Date of Event
February 5, 1994
Report Date
April 27, 1994
Manufacturer
BECTON DICKINSON
Product Code
DQO
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
VA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT WAS ADMITTED DUE TO RAPIDLY PROGRESSIVE DYSPNEA CAUSING RESPIRATORY FAILURE AND APNEA WHICH WAS FOUND TO BE DUE TO ACIDOTIC INITIALLY ALTHOUGH THIS IMPROVED OVER THE NEXT FEW HOURS. NEUROLOGICALLY SHE REMAINED COMATOSE, HOWEVER, AND NEVER REGAINED ANY FUNCTIONAL NEUROLOGIC IMPROVEMENT. INITIAL CPK ON ADMISSION WAS 147 WITH SUBSEQUENT CPK 560. INITIAL LDH ON ADMISSION WAS 792 WITH FURTHER INCREASE BY THE NEXT MORNING TO 1,096. AST WAS ALSO ELEVATED. ISOS WERE STILL PENDING AT THE TIME OF DICTATION.AN ECHOCARDIOGRAM REVEALED MODERATE CONCENTRIC LVH WITH MILD TO MODERATE GLOBAL HYPOKINESIS AND AN EJECTION FRACTION OF 35-40%. WITH CORRECTION OF HER METABOLIC ABNORMALITIES AND SPECIFICALLY THE METABOLIC ACIDOSIS, THE PATIENT CONTINUED TO EXHIBIT HYPOKALEMIA WHICH REQUIRED SUPPLEMENTATION, AND MILD HYPOMAGNESSEMIA. THE PATIENT WAS ALSO SEEN BY NEUROLOGY. AN EEG WAS PERFORMED WHICH REVEALED A BURST SUPPRESSION PATTERN SUGGESTIVE OF SEVERE DIFFUSE BIHEMISPHERIC NEURONAL DYSFUNCTION, HOWEVER, NO EPILEPTIFORM ABNORMALITIES WERE NOTED. THE PATIENT HAD NOT REGAINED ANY DEMONSTRABLE NEURONAL FUNCTION BY THE NEXT MORNING.SHE WAS STARTED ON ANTIBIOTICS FOR SUSPECTED ASPIRATION PNEUMONIA. VASCULAR ACCESS REMAINED A SEVERE PROBLEM AND A CENTRAL LINE WAS THEREFORE PLACED. LATER THAT SAME DAY, THE PATIENT LOST HER PULSE AND BLOOD PRESSURE AND RESUSCITATIVE EFFORTS WERE INITIATED. DESPITE MAXIMAL ATTEMPTS AT RESUSCITATION, NO PULSE OR BLOOD PRESSURE COULD BE OBTAINED AND THE PATIENT WAS THEREFORE PRONOUNCED DEAD AT 11:15. AUTOPSY WAS PENDING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SAFE DWEL PLUS TRIPLE LUMEN VENOUS ACCESS CATHETER DQO BECTON DICKINSON UNKNOWN UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 39 YR Death