FDA Adverse Event Malfunction Summary report: N

FOLFUSOR

MDR report key: 3853151 · Received June 6, 2014

Report

Report Number: 1416980-2014-18145
Event Type: Malfunction
Date Received: June 6, 2014
Report Date: May 13, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). THE LOT 14A027 WAS MANUFACTURED BETWEEN NOVEMBER 16, 2014 AND NOVEMBER 17, 2014. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

A CUSTOMER REPORTED EXPERIENCING AN UNDER-INFUSION WHILE USING A FOLFUSOR ELASTOMERIC DEVICE. THE DEVICE CONTAINED AN UNSPECIFIED CHEMOTHERAPEUTIC SOLUTION. THE CUSTOMER INDICATED THAT, AFTER THE PRESCRIBED INFUSION DURATION OF 44 HOURS, THERE WAS STILL 20-30ML LEFT IN THE DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
332478	FOLFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		14A027

Patients

Seq	Age	Sex	Outcome	Treatment
1				UNKNOWN CHEMOTHERAPEUTIC SOLUTION