FDA Adverse Event Malfunction Summary report: N

COLLEAGUE PRE P1.7

MDR report key: 2143312 · Received June 28, 2011

Report

Report Number: 6000001-2011-09156
Event Type: Malfunction
Date Received: June 28, 2011
Date of Event: June 3, 2011
Report Date: June 3, 2011
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FRN
PMA / PMN Number: K063696
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATION: THE REPORTED MALFUNCTION OF A COLLEAGUE INFUSION PUMP EXPERIENCED FAILURE CODE 403 WAS CONFIRMED AND NOT REPRODUCED. THE ROOT CAUSE WAS ATTRIBUTED TO A USER INTERFACE MODULE PRINTED CIRCUIT BOARD. THE USER INTERFACE MODULE BOARD WAS REPLACED TO FIX THE PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.92. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED FAILURE CODE 403. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLLEAGUE PRE P1.7	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1