FDA Adverse Event Malfunction Summary report: N

COLLEAGUE CXE VOLUMETRICINFUSION PUMP

MDR report key: 1760441 · Received July 19, 2010

Report

Report Number: 6000001-2010-01741
Event Type: Malfunction
Date Received: July 19, 2010
Date of Event: May 8, 2010
Report Date: June 25, 2010
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FRN
PMA / PMN Number: K063696
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF FAILURE CODE 810:11 AND DETERMINED THE ROOT CAUSE TO AN OUT OF CALIBRATION AIR IN LINE PRINTED CIRCUIT BOARD. THE AIR IN LINE PRINTED CIRCUIT BOARD WAS CALIBRATED TO REPAIR THIS CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

Description of Event or Problem · 1

THE BAXTER PRODUCT ANALYSIS LAB TECHNICIAN REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED FAILURE 810:11. IT WAS DETERMINED FROM THE DEVICE EVENT LOG THAT THIS CONDITION INTERRUPTED DELIVERY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, WHICH IS CLASSIFIED AS COLLEAGUE 2006 (REMEDIATED). NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLLEAGUE CXE VOLUMETRICINFUSION PUMP	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1