FDA Adverse Event Malfunction Summary report: N

COLLEAGUE PRE P1.7

MDR report key: 2090326 · Received May 16, 2011

Report

Report Number: 6000001-2011-04101
Event Type: Malfunction
Date Received: May 16, 2011
Date of Event: March 12, 2011
Report Date: May 9, 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: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER AT THIS TIME.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION AND THE REPORTED CONDITION WAS CONFIRMED IN THE EVENT HISTORY BUT NOT DUPLICATED. THIS COMPLAINT IS AN ANCILLARY OF (B)(4). THE DEVICE PASSED TESTING AND NO FAILURE COULD BE DETECTED. THE CAUSE OF THE EVENT IS UNKNOWN. NO REPAIRS WERE PERFORMED TO CORRECT THE REPORTED CONDITION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

Description of Event or Problem · 1

DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND WITH AN UPSTREAM OCCLUSION SET B ALARM, WHICH INTERRUPTED DELIVERY. THIS ALARM MAY HAVE BEEN A FALSE ALARM. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.

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