FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 3834214 · Received May 27, 2014

Report

Report Number: 1416980-2014-17145
Event Type: Malfunction
Date Received: May 27, 2014
Date of Event: May 2, 2014
Report Date: May 2, 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 CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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). THIS LOT WAS MANUFACTURED BETWEEN JANUARY 15, 2013 AND JANUARY 16, 2013. EVALUATION SUMMARY: BAXTER RECEIVED ONE UNIT FOR EVALUATION. VISUAL INSPECTION NOTED WHITE PARTICLES BETWEEN 0.10 TO 4.00 MM IN SIZE, FLOATING IN THE FLUID OF THE BLADDER. FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY IDENTIFIED THE WHITE PARTICLES TO BE ACRYLIC MATERIAL. THE CAUSE OF THE PARTICULATE MATTER 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 PARTICULATE MATTER WAS OBSERVED INSIDE OF THE RESERVOIR OF A LARGE VOLUME INTERMATE. THIS WAS IDENTIFIED DURING FILLING WITH A COMPOUNDED SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310310	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		14A034

Patients

Seq	Age	Sex	Outcome	Treatment
1