FDA Adverse Event Death Summary report: N

PLUM XL MICRO/MACRO PUMP

MDR report key: 599642 · Received May 4, 2005

Report

Report Number
2921482-2005-00259
Event Type
Death
Date Received
May 4, 2005
Date of Event
April 7, 2005
Report Date
April 7, 2005
Manufacturer
HOSPIRA, INC.
Product Code
FRN
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 PATIENT DEATH WHILE DEVICE WAS IN USE. THE PUMP WAS PROGRAMMED TO DELIVER LACTATED RINGERS AT A RATE OF 125ML/HOUR. 2005 AT 0600 DURING END OF SHIFT ROUNDS, THE NIGHT NURSE REPORTED THAT THE PATIENT WAS AWAKENED AND VITAL SIGNS WERE TAKEN; HOWEVER THE PATIENT REPORTEDLY WAS, "SNORING LOUDLY THROUGHT OUT THE NIGHT." THE CUSTOMER CONTACT STATED, "THE NURSE FELT A SLEEP APNEA STUDY WAS A GOOD IDEA." REPORTEDLY AT 0800, DURING INITIAL ROUNDS, THE DAY SHIFT NURSE FOUND THE PATIENT HAD EXPIRED. A CODE WAS CALLED. THE CUSTOMER CONTACT REPORTED THAT THE PATIENT "WAS NOT BLUE" AND THERE WAS "NO POOLING OF BLOOD." REPORTEDLY THE PATIENT HAD "A FINE V-FIB" WHEN THEY WERE PUT "ON THE MONITOR." CPR WAS PERFORMED. THE PATIENT WAS TREATED WITH UNSPECIFIED DOSE OF EPINEPHRINE, AMIODARONE, NARCAN, AND WAS DEFIBRILLATED THREE TIMES WITH 200, 300 AND 360 JOULES RESPECTIVELY. THE PATIENT WAS PRONOUNCED DEAD AT 0835. INITIAL CAUSE OF DEATH IS UNDETERMINED. THE CUSTOMER CONTACT NOTED THERE WAS 12ML REMAINING IN THE MORPHINE SYRINGE AS EXPECTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PLUM XL MICRO/MACRO PUMP INFUSION PUMP FRN HOSPIRA, INC. NA NA

Patients

Seq Age Sex Outcome Treatment
1 50 YR Death PCA PLUS II, LIST#01950.