FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 3820056 · Received May 20, 2014

Report

Report Number: 1416980-2014-16216
Event Type: Malfunction
Date Received: May 20, 2014
Date of Event: April 24, 2014
Report Date: April 25, 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). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS MANUFACTURED BETWEEN NOVEMBER 18, 2013 ¿ NOVEMBER 19, 2013. EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED THE LEAK INSIDE THE OVERPOUCH OF THE DEVICE. THE CAUSE OF THE REPORTED PROBLEM WAS DUE TO BROKEN TUBING AT THE JUNCTION OF THE DISTAL LUER POST. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT AN INTERMATE ELASTOMERIC DEVICE LEAKED AFTER THE DEVICE WAS REMOVED FROM IT'S SHIPPING BOX. IT WAS NOTED THAT THERE WAS APPROXIMATELY 100ML IN THE OVER-POUCH(PAMIDRONATE 90MG IN 250 ML NACL). THE LOCATION OF THE LEAK WAS UNKNOWN. THIS OBSERVATION WAS MADE PRIOR TO PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
300089	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		13M079

Patients

Seq	Age	Sex	Outcome	Treatment
1