FDA Adverse Event Malfunction Summary report: N

FOLFUSOR

MDR report key: 3871533 · Received June 13, 2014

Report

Report Number: 1416980-2014-18862
Event Type: Malfunction
Date Received: June 13, 2014
Date of Event: May 17, 2014
Report Date: May 20, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LOT WAS MANUFACTURED FROM MARCH 20, 2013 TO MARCH 21, 2013. EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED NO SIGNS OF BLOCKAGE OR PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED PROBLEM. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED BY REMOVING THE DISTAL LUER CAP; FLOW WAS THEN OBSERVED AT THE DISTAL LUER. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR DID NOT FLOW. THIS OCCURRED DURING PATIENT INFUSION OF FLUOROURACIL. THERE WAS NO REPORT OF 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
349828	FOLFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		13C065

Patients

Seq	Age	Sex	Outcome	Treatment
1				FLUOROURACIL