FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 4122478 · Received September 26, 2014

Report

Report Number: 1416980-2014-33414
Event Type: Malfunction
Date Received: September 26, 2014
Date of Event: August 29, 2014
Report Date: September 2, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: FRN
PMA / PMN Number: K910425
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LOT WAS MANUFACTURED BETWEEN NOVEMBER 18, 2013 AND NOVEMBER 19, 2013. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED BROKEN TUBING AT THE JUNCTION OF THE DISTAL LUER LOCK. THE CAUSE OF THE TUBING COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION. 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). THIS ISSUE IS CURRENTLY BEING ADDRESSED THROUGH A CAPA. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LARGE VOLUME INTERMATE LEAKED. THE DEVICE WAS FILLED WITH PAMIDRONATE 90MG IN 250ML OF SODIUM CHLORIDE SOLUTION. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
600656	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		13M079

Patients

Seq	Age	Sex	Outcome	Treatment
1