FDA Adverse Event Malfunction Summary report: N

PLUM XL

MDR report key: 1870389 · Received September 24, 2010

Report

Report Number
1870389
Event Type
Malfunction
Date Received
September 24, 2010
Date of Event
January 4, 2010
Report Date
September 24, 2010
Manufacturer
HOSPIRA, INC.
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

AT 10:45 AM PATIENT FROM CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) WAS SENT TO VENTILATION/PERFUSION LUNG (VQ) SCAN, ECHOCARDIOGRAM AND PRE-OPERATIVE. THE PATIENT WAS SENT WITH TWO IV PUMPS, ONE RUNNING FLUIDS AT 125CC/HR AND A SECOND WITH A HEPARIN DRIP AT 10CC/HR. AT APPROXIMATELY 12:30 AM, AN ECHO TECH TOLD CVICU RN THE HEPARIN BAG WAS EMPTY. RN WENT TO ECHOCARDIOGRAM AND HUNG A NEW HEPARIN BAG 25,000 UNITS IN 250CC AND PROGRAMMED IV PUMP TO 10CC PER HOUR. FOLLOWING THE ECHO, THE PATIENT WAS TRANSPORTED TO PRE-OPERATIVE. ACCORDING TO PRE-OPERATIVE RN, BOTH IV PUMPS WERE OFF WHEN PATIENT ARRIVED IN PRE-OPERATIVE. ECHOCARDIOGRAM TECHNICIAN STATED SHE CALLED THE CVICU RN WHEN THE HEPARIN BAG WAS EMPTY AND THE CVICU RN CAME TO CHANGE THE BAG; ECHOCARDIOGRAM TECHNICIAN DID NOT TOUCH THE PUMPS OR IVS. WHEN THE PATIENT WAS RETURNED TO CVICU, IT WAS NOTICED THAT THE HEPARIN BAG WAS EMPTY. DOCTOR WAS NOTIFIED AND LABS DRAWN, WHILE THE PATIENT WAS MONITORED CLOSELY. LAB REPORT AT 15:52 INDICATED THE PATIENT WAS 20.6 AND PARTIAL THROMBOPLASTIN TIME (PTT) WAS 62.8. NEXT DAY AT 04:35 THE PATIENT WAS 19.2 AND PTT 35.3. THE SUSPECT IV PUMP, IV TUBING SET AND EMPTY HEPARIN BAG WERE SENT TO BIOMED FOR INVESTIGATION. AFTER TALKING WITH DOCTOR, HE IS NOT FOR SURE HOW MUCH HEPARIN THE PATIENT RECEIVED BECAUSE THE LABS VALUES DO NOT REFLECT THIS AMOUNT OF HEPARIN BOLUS. NEXT DAY, THE PATIENT'S HEMOGLOBIN REMAINED STABLE AT 10.7. WILL CONTINUE TO FOLLOW.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PLUM XL INFUSION PUMP, GENERAL PURPOSE FRN HOSPIRA, INC. 11859-04-03 *

Patients

Seq Age Sex Outcome Treatment
1 54 YR