FDA Adverse Event Malfunction Summary report: N

INFUSOR LV5, 12 PK

MDR report key: 1820395 · Received August 30, 2010

Report

Report Number: 6000001-2010-02865
Event Type: Malfunction
Date Received: August 30, 2010
Date of Event: August 5, 2010
Report Date: August 5, 2010
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED AT BAXTER FOR EVALUATION. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOME AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED AND EVALUATED BY BAXTER. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. A BATCH REVIEW HAS BEEN PERFORMED. ALL OF THE RELEASE CRITERIA HAVE BEEN MET FOR THE PRODUCTION OF THIS LOT.

Description of Event or Problem · 1

THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN OVERINFUSION. THE EVENT OCCURRED DURING PATIENT THERAPY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

Description of Event or Problem · 1

ROUTINE TESTING DONE PRIOR TO DEVICE RESTOCK NOTED A LOW BATTERY VOLTAGE. THE DEVICE WAS RECEIVED IN THE UNOPENED ORIGINAL SHIPPING PACKAGE AND WAS SENT FOR FURTHER ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSOR LV5, 12 PK	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1