FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 3874909 · Received June 16, 2014

Report

Report Number: 1416980-2014-19142
Event Type: Malfunction
Date Received: June 16, 2014
Date of Event: May 22, 2014
Report Date: May 22, 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). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS MANUFACTURED BETWEEN FEBRUARY 27, 2014 AND MARCH 4, 2014. EVALUATION SUMMARY: BAXTER RECEIVED THE UNIT FOR EVALUATION. VISUAL INSPECTION NOTED WHITE PARTICLES BETWEEN 0.30 TO 3.60 MM IN SIZE, FLOATING IN THE FLUID OF THE BLADDER, IN THE FLUID PATH. THE PARTICLES WERE IDENTIFIED TO BE ACRYLIC MATERIAL VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) SPECTROPHOTOMETER SCANNING. THE CAUSE COULD NOT BE DETERMINED. A CAPA HAS BEEN INITIATED TO INVESTIGATE THIS ISSUE. 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 A LARGE VOLUME INTERMATE HAD PARTICULATE MATTER WITHIN THE BLADDER. THIS WAS IDENTIFIED DURING FILLING WITH AN UNSPECIFIED DRUG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 5.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352373	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		14B047

Patients

Seq	Age	Sex	Outcome	Treatment
1