FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 3802702 · Received May 9, 2014

Report

Report Number: 1416980-2014-14966
Event Type: Malfunction
Date Received: May 9, 2014
Report Date: April 14, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: FRN
PMA / PMN Number: K853881
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THIS LOT WAS MANUFACTURED BETWEEN APRIL 15, 2011 AND APRIL 20, 2011. EVALUATION SUMMARY: BAXTER RECEIVED ONE UNIT FOR EVALUATION. VISUAL INSPECTION SHOWED NO SIGNS OF OBVIOUS PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED LEAK. A FUNCTIONAL LEAK TEST WAS PERFORMED AND A LEAK WAS OBSERVED ON THE TUBING LOCATED INSIDE THE HOUSING; THERE WAS A CUT ON THE TUBING. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS 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 LEAKAGE WAS OBSERVED FROM THE BOTTOM OF AN INFUSOR PATIENT CONTROL MODULE WATCH CHAMBER. IT WAS REPORTED THAT THIS OCCURRED DURING FILLING OF THE DEVICE WITH ¿SUFENTAL-290, EMCAINE-20, ROPIVA-10¿ AND NORMAL SALINE FOR A TOTAL FILL VOLUME OF 100ML. THE REPORTER STATED THAT THE RESERVOIR DID NOT APPEAR TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
280644	INFUSOR	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		11D067

Patients

Seq	Age	Sex	Outcome	Treatment
1