FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 3855170 · Received June 9, 2014

Report

Report Number: 1416980-2014-18308
Event Type: Malfunction
Date Received: June 9, 2014
Date of Event: May 14, 2014
Report Date: May 14, 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). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS MANUFACTURED BETWEEN JANUARY 15, 2013 ¿ JANUARY 16, 2013. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED WHITE PARTICLES BETWEEN 0.04 TO 4.50 MM IN SIZE, FLOATING IN THE FLUID OF THE BLADDER. THE PARTICLES WERE IN THE FLUID PATH. THE PARTICLES WERE IDENTIFIED TO BE ACRYLIC MATERIAL VIA FTIR SPECTROPHOTOMETRIC SCANNING. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS 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 THERE WAS PARTICULATE MATTER IN THE BALLOON OF A LARGE VOLUME INTERMATE. THIS WAS NOTED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
334669	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		14A034

Patients

Seq	Age	Sex	Outcome	Treatment
1