FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 3790820 · Received May 5, 2014

Report

Report Number: 1416980-2014-14495
Event Type: Malfunction
Date Received: May 5, 2014
Date of Event: April 10, 2014
Report Date: April 10, 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. A BATCH REVIEW WILL BE PERFORMED. UPON COMPLETION OF BAXTER'S INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE LOT 14A034, WAS MANUFACTURED BETWEEN JANUARY 15, 2013 AND JANUARY 16, 2013. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE VISUAL INSPECTION (VIA THE NAKED EYE) ON THE TWO UNITS NOTED PARTICLES RANGING BETWEEN 1.30 TO 2.00 MM IN SIZE, FLOATING INSIDE THE FLUID OF THE BLADDER. THE PARTICLES WERE IN THE FLUID PATH. THE CONDITION WAS VERIFIED VIA THE SAMPLE EVALUATION. THE CAUSE/ORIGIN OF THE PARTICULATE MATTER COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PARTICLES WERE IDENTIFIED INSIDE OF THE BLADDER OF A LARGE VOLUME INTERMATE. THIS WAS NOTICED AFTER FILLING WITH AN UNSPECIFIED SOLUTION AND BEFORE PATIENT CONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
267690	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		14A034

Patients

Seq	Age	Sex	Outcome	Treatment
1