FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 2873200 · Received December 13, 2012

Report

Report Number: 1416980-2012-07331
Event Type: Malfunction
Date Received: December 13, 2012
Date of Event: November 8, 2012
Report Date: November 20, 2012
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
PMA / PMN Number: K071222
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED.

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

BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD NO FLOW DURING PATIENT USE. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THIS CONDITION INTERRUPTED THERAPY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		12B007

Patients

Seq	Age	Sex	Outcome	Treatment
1