FDA Adverse Event Death Summary report: N

LIFECARE PCA PLUS INFUSER

MDR report key: 599582 · Received May 4, 2005

Report

Report Number
2921482-2005-00262
Event Type
Death
Date Received
May 4, 2005
Date of Event
April 7, 2005
Report Date
April 7, 2005
Manufacturer
HOSPIRA, INC.
Product Code
MEA
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

REPORT RECEIVED OF A PT DEATH WHILE THE DEVICE WAS IN USE. THE PUMP WAS PROGRAMMED TO DELIVER 1MG/ML OF MORPHINE IN THE PCA + CONTINUOUS MODE, A 2MG/HR CONTINUOUS RATE, A 1MG PCA DOSE, 10 MINUTE PT LOCKOUT AND 30MG 4 HOUR LIMIT. IN 2005 AT 0600 DURING END OF SHIFT ROUNDS, THE NIGHT NURSE REPORTED THAT THE PT WAS AWAKENED AND VITAL SIGNS WERE TAKEN; HOWEVER THE PT REPORTEDLY WAS, "SNORING LOUDLY THROUGH OUT THE NIGHT." THE CUSTOMER CONTACT STATED, "THE NURSE FELT A SLEEP APNEA STUDY WAS A GOOD IDEA." REPORTEDLY AT 0800, DURING THE INITIAL ROUNDS, THE DAY SHIFT NURSE FOUND THE PT HAD EXPIRED. A CODE WAS CALLED. THE CUSTOER CONTACT REPORTED THAT THE PT "WAS NOT BLUE" AND THERE WAS "NO POOLING OF BLOOD." REPORTEDLY, THE PT HAD "A FINE V-FIB" WHEN THEY WERE PUT "ON THE MONITOR." CPR WAS PERFORMED, THE PT WAS TREATED WITH UNSPECIFIED DOSES OF EPINEPHRINE, AMIODARONE, NARCAN, AND WAS DEFIBRILLATED THREE TIMES WITH 200, 300 AND 360 JOULES RESPECTIVELY. THE PT WAS PRONOUNCED DEAD AT 0835. INITIAL CAUSE OF DEATH IS UNDETERMINED. THE CUSTOMER CONTACT NOTED THERE WAS 12ML REMAINING IN THE MORPHINE SYRINGE AS EXPCTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIFECARE PCA PLUS INFUSER PCA INFUSION PUMP MEA HOSPIRA, INC. NA NA

Patients

Seq Age Sex Outcome Treatment
1 50 YR Death PLUM XL PUMP, LIST#11846, MORPHINE| MANUFACTURER UNK