FDA Adverse Event Injury Summary report: N

PLUM XL3M MICRO/MARCRO PUMP

MDR report key: 608011 · Received May 18, 2005

Report

Report Number
2921482-2005-00285
Event Type
Injury
Date Received
May 18, 2005
Date of Event
April 17, 2005
Report Date
April 22, 2005
Manufacturer
HOSPIRA, INC.
Product Code
FRN
Removal / Correction Number
NA
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

AT 2215, CHANNEL C WAS PROGRAMMED TO DELIVER 0.5 MG/500 ML OF AMIODARONE AT A RATE OF 17 ML/HR (INSTEAD OF THE INITIALLY REPORTED RATE OF 12 ML) WITH A VOLUME TO BE INFUSED (VTBI) OF 500 ML AND THE DELIVERY WAS STARTED NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 2300, WHILE RESPONDING TO A "LOW BP" (BLOOD PRESSURE) ALARM, THE RN NOTED THE BAG HAD 50 ML REMAINING AND THAT APPROX 450 ML WAS DELIVERED. THE THERAPY WAS STOPPED. TWO RNS VERIFIED THE PUMP SETTINGS. REPORTEDLY, THE DEVICE DISPLAYED A RATE OF 17 ML/HR, A VOLUME INFUSED OF 12 ML, AND A VTBI OF 488 ML. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE PT WAS TREATED WITH A 1L BOLUS OF NS AND 400 MG/ 500 ML OF DOPAMINE AT A DOSE OF 3 MCG/KG/MIN. THE DOPAMINE WAS INCREASED TO 5.14 MCG/KG/MIN AND THEN TITRATED TO MAINTAIN THE PT'S BP. IN 04/2005 AT 0300, THE PT'S BP HAD STABILIZED. THERE WERE NO REPORTED ADVERSE PT SEQUENLAE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PLUM XL3M MICRO/MARCRO PUMP INFUSION PUMP FRN HOSPIRA, INC. NA NA

Patients

Seq Age Sex Outcome Treatment
1 * Life Threatening| R