INFUSOR

MDR report key: 3961753 · Received July 28, 2014

Report

Report Number: 1416980-2014-24482
Event Type: Malfunction
Date Received: July 28, 2014
Date of Event: July 3, 2014
Report Date: July 3, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
PMA / PMN Number: K071222
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS MANUFACTURED BETWEEN APRIL 18, 2014 - APRIL 19, 2014. EVALUATION SUMMARY: BAXTER RECEIVED THE UNIT FOR EVALUATION WITH FLUID IN THE PACKAGING. VISUAL INSPECTION IDENTIFIED AN UNTIGHTENED BLUE WINGED LUER CAP. A FUNCTIONAL LEAK TEST WAS PERFORMED, THE BLUE WINGED CAP WAS TIGHTENED, AND THE UNIT WAS MONITORED. THE NEXT DAY, NO SIGNS OF LEAK WERE OBSERVED AT THE BLUE WINGED LUER CAP. 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 A LARGE VOLUME INFUSOR LEAKED BEFORE USE. THE LEAK WAS NOTED UPON UNPACKING THE DEVICE, WHEN THE FLUID WAS NOTED IN THE OVERPOUCH. THE REPORTER STATED THAT THEY DID NOT NOTICE ANY ISSUES WITH THE PACKAGING AND DID NOT KNOW THE SOURCE OF THE LEAK. THE DEVICE WAS FILLED WITH 4400 MG FLUOROURACIL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
439664	INFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		14D031

Patients

Seq	Age	Sex	Outcome	Treatment
1