FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 3851071 · Received June 5, 2014

Report

Report Number: 1416980-2014-17976
Event Type: Malfunction
Date Received: June 5, 2014
Date of Event: April 30, 2014
Report Date: May 12, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
PMA / PMN Number: K071222
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS LOT WAS MANUFACTURED BETWEEN NOVEMBER 26, 2013 AND NOVEMBER 27. EVALUATION SUMMARY: BAXTER RECEIVED ONE UNIT FOR EVALUATION. VISUAL INSPECTION SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED ON THE UNIT AND WAS FOUND TO BE WITHIN SPECIFICATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LARGE VOLUME INFUSOR OVERINFUSED. THE REPORTER STATED THAT THE DEVICE WAS FILLED WITH FLUOROURACIL AND WAS EXPECTED TO FULLY DELIVER ITS CONTENTS IN 46 HOURS, BUT THE INFUSION WAS COMPLETED IN 34 HOURS. THE PATIENT STATED THAT THEY WERE NOT IN A SHOWER OR HEATED AREA, THE DEVICE WAS AROUND THEIR NECK, AND THEY SLEPT ON THEIR SIDE ALL NIGHT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
330094	INFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		13M091

Patients

Seq	Age	Sex	Outcome	Treatment
1				FLUOROURACIL