FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 3953779 · Received July 23, 2014

Report

Report Number: 1416980-2014-23952
Event Type: Malfunction
Date Received: July 23, 2014
Date of Event: May 28, 2014
Report Date: June 30, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
PMA / PMN Number: K062457
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS MANUFACTURED BETWEEN DECEMBER 18, 2012 AND DECEMBER 19, 2012. AS THE SAMPLE WAS NOT RETURNED; A DEVICE ANALYSIS CANNOT BE COMPLETED. 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). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT AN INFUSOR DID NOT INFUSE. WHEN THE PATIENT RETURNED TO THE OFFICE IT WAS NOTED THAT VERY LITTLE FLUOROURACIL HAD INFUSED. THE INFUSION SITE WAS CHECKED AND THE HUB OF THE CATHETER WAS RETAPED TO THE PATIENT¿S CHEST. THE PATIENT CAME BACK THE NEXT DAY AND IT WAS NOTICED THAT NO MORE OF THE DRUG HAD INFUSED. THE DEVICE WAS SWAPPED OUT AND THERAPY WAS CONTINUED ON A PUMP WITH A DIFFERENT LOT NUMBER. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
431164	INFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		12N046

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR			FLUOROURACIL