FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 3802462 · Received May 9, 2014

Report

Report Number: 1416980-2014-14918
Event Type: Malfunction
Date Received: May 9, 2014
Date of Event: April 16, 2014
Report Date: April 16, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: FRN
PMA / PMN Number: K910425
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EI
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS MANUFACTURED NOVEMBER 7, 2013 ¿ NOVEMBER 8, 2013. EVALUATION SUMMARY: THE USED DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A BLACK ELONGATED PARTICLE 2.6 MM LONG AND ALSO ONE ROUND BLACK PARTICLE 0.1 MM IN SIZE, EMBEDDED IN THE MATERIAL OF THE STRESS-MEMBER COLUMN. THE PARTICLES WERE NOT IN THE FLUID PATH. SPECTROPHOTOMETRIC ANALYSIS OF THE PARTICLES REVEALED THAT THEY WERE MADE OF WOOD. THE CAUSE OF THE CONDITION WAS NOT 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.

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A LARGE BLACK MARK ON THE STRESS MEMBER OF A SMALL VOLUME INTERMATE. THIS WAS NOTED AFTER THE DEVICE HAD BEEN FILLED WITH COLISTIMETHATE, BUT BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
281578	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		13M013

Patients

Seq	Age	Sex	Outcome	Treatment
1