FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 3123299 · Received May 21, 2013

Report

Report Number: 1416980-2013-13101
Event Type: Malfunction
Date Received: May 21, 2013
Date of Event: April 30, 2013
Report Date: April 30, 2013
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. NO ABNORMALITIES OR MALFUNCTIONS WERE OBSERVED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS AN OVERINFUSION OF A BOLUS INFUSOR 2 ML X 2 ML. THE INFUSOR DEVICE WAS FILLED WITH 100ML OF ROPIVACAINE HYDROCHLORIDE HYDRATE. THE EXPECTED FLOW RATE WAS 100 ML IN 48 HOURS, BUT THE INFUSION ENDED WITH AN ACTUAL FLOW RATE OF 100 ML IN 24 HOURS. THIS OCCURRED DURING PATIENT INFUSION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
224673	INFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		12N047

Patients

Seq	Age	Sex	Outcome	Treatment
1				ROPIVACAINE HYDROCHLORIDE HYDRATE