FDA Adverse Event Malfunction Summary report: N

CE INFUSOR LV10, 12 PACK

MDR report key: 1932453 · Received December 17, 2010

Report

Report Number: 6000001-2010-05925
Event Type: Malfunction
Date Received: December 17, 2010
Date of Event: November 24, 2010
Report Date: November 24, 2010
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
PMA / PMN Number: K041738
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EXAMINATION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A LEAK. THE ROOT CAUSE WAS DETERMINED TO BE BROKEN TUBING. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR LV 10 DEVICE WAS LEAKING FROM THE BLUE WINGED CAP BEFORE USE. THE DEVICE HAD BEEN FILLED WITH 8000 MILLIGRAMS FLUCLOXACILLIN IN 0.9% NACL DILUENT WHEN THE LEAK WAS OBSERVED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CE INFUSOR LV10, 12 PACK	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		10G045

Patients

Seq	Age	Sex	Outcome	Treatment
1