FDA Adverse Event Malfunction Summary report: N

FOLFUSOR

MDR report key: 3852230 · Received June 5, 2014

Report

Report Number: 1416980-2014-17975
Event Type: Malfunction
Date Received: June 5, 2014
Report Date: May 12, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE UNIT FOR EVALUATION FILLED WITH APPROXIMATELY 105ML IN ITS BLADDER. VISUAL INSPECTION SHOWED NO SIGNS OF BLOCKAGE OR PHYSICAL ABNORMALITY. A FUNCTIONAL TEST WAS PERFORMED BY REMOVING THE LUER CAP FROM THE UNIT¿S DISTAL LUER AND EVIDENCE OF FLOW WAS VISUALLY OBSERVED AT THE DISTAL LUER. THE UNIT WAS 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). (THERAPY DATES) - THE EVENT OCCURRED FROM (B)(6) 2014 TO (B)(6) 2014. THE LOT 13H048 WAS MANUFACTURED BETWEEN AUGUST 15, 2013 ¿ AUGUST 16, 2013. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR DID NOT FLOW. THIS OCCURRED DURING PATIENT INFUSION OF FLUOROURACIL (NON-BAXTER PRODUCT) AND WAS NOTICED TWO DAYS AFTER THE DEVICE WAS CONNECTED TO THE PATIENT. 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
329256	FOLFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		13H048

Patients

Seq	Age	Sex	Outcome	Treatment
1				FLUOROURACIL (NON-BAXTER PRODUCT)