FOLFUSOR

Report

Report Number: 1416980-2014-21564
Date Received: July 3, 2014
Date of Event: May 19, 2014
Report Date: June 10, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. A VISUAL INSPECTION WAS PERFORMED. WHEN THE LUER CAP WAS REMOVED IT WAS DETERMINED THAT THE DEVICE WAS NOT FLOWING. A FORCE PRIME WAS ATTEMPTED, BUT NO FLOW WAS OBSERVED. UPON CLOSER INSPECTION IT WAS FOUND THAT THERE WAS CRYSTALLIZED DRUG BLOCKING THE FLUID PATH AT THE DISTAL END OF THE GLASS CAPILLARY LOCATED INSIDE THE FLOW RESTRICTOR HOUSING. THE CAUSE OF THE CRYSTALIZED DRUG IS UNKNOWN. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LARGE VOLUME FOLFUSOR HAD FLOW STOP DURING AN INFUSION. THE REPORTER STATED THAT THE NO FLOW WAS NOTICED AFTER 72 HOURS OF INFUSION. THE DEVICE WAS FILLED WITH FLUOROURACIL AND AN UNKNOWN DILUENT. 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
389762	FOLFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		14C009

Patients

Seq	Age	Sex	Outcome	Treatment
1				FLUOROURACIL\| UNKNOWN DILUENT