FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 2243774 · Received September 12, 2011

Report

Report Number: 6000001-2011-23926
Event Type: Malfunction
Date Received: September 12, 2011
Date of Event: August 18, 2011
Report Date: August 18, 2011
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
PMA / PMN Number: K041738
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE; A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. VISUAL EXAMINATION OF THE UNIT DID CONFIRM THE DETACHED COIL CAP CONDITION. THE ROOT CAUSE OF THE DETACHED COIL CAP CONDITION IS DUE TO THE UNIT BEING EXPOSED TO HIGH TEMPERATURES DURING SHIPPING, CAUSING THE COVER TO MELT. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. NO OTHER OBSERVATION WAS FOUND ON THE UNIT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

Description of Event or Problem · 1

BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) INFUSOR DEVICE WAS DEFORMED IN SHAPE AND PURPLE LIDS ARE OUT FROM INFUSOR BEFORE USE. THIS OCCURRED PRIOR TO FILLING. THERE WAS NO PATIENT INVOLVEMENT REPORTED FOR THIS COMPLAINT. THE ACTUAL SAMPLE IS AVAILABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED DURING INITIAL REPORT. NO ADDITIONAL INFORMATION AVAILABLE. REPORT 1 OF 4.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		11A020

Patients

Seq	Age	Sex	Outcome	Treatment
1