FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 3961273 · Received July 28, 2014

Report

Report Number: 1416980-2014-24234
Event Type: Malfunction
Date Received: July 28, 2014
Date of Event: July 1, 2014
Report Date: July 1, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: FRN
PMA / PMN Number: K910425
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER; EVALUATION IS CURRENTLY IN PROCESS BUT HAS NOT YET BEEN COMPLETED. 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). MANUFACTURE DATE APRIL 8, 2014 TO APRIL 10, 2014. EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION WHITE PARTICLES RANGING IN SIZE FROM 0.15 ¿ 0.25 MM WERE OBSERVED FLOATING WITHIN THE FLUID OF THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY DETERMINED THE PARTICLES TO BE ACRYLIC MATERIAL. THE REPORTED PROBLEM WAS VERIFIED. THE CAUSE OF THE PROBLEM IS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT AN INTERMATE HAD PARTICULATE MATTER INSIDE THE BLADDER OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
438031	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		14D012

Patients

Seq	Age	Sex	Outcome	Treatment
1