COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

MDR report key: 2033590 · Received March 30, 2011

Report

Report Number: 6000001-2011-02345
Event Type: Malfunction
Date Received: March 30, 2011
Date of Event: March 10, 2011
Report Date: March 10, 2011
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FRN
PMA / PMN Number: K041191
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

IT WAS REPORTED BY BAXTER SERVICE PERSONNEL THAT A COLLEAGUE INFUSION PUMP EXPERIENCED AN 810:03 FAILURE CODE. THIS EVENT OCCURRED DURING SERVICE/TESTING AND MAY HAVE INTERRUPTED DELIVERY.

Description of Event or Problem · 1

THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED AN 810:03 FAILURE CODE. IT IS UNKNOWN WHICH PROCESS STEP THIS EVENT OCCURRED DURING. UPON REVIEW OF THE EVENT HISTORY, QUALITY ENGINEERING DETERMINED THAT THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, AND THEREFORE NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE INFUSION PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1