FDA Adverse Event Malfunction Summary report: N

COLLEAGUE PRE P1.7

MDR report key: 2110507 · Received June 1, 2011

Report

Report Number: 6000001-2011-06892
Event Type: Malfunction
Date Received: June 1, 2011
Date of Event: April 20, 2011
Report Date: May 4, 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.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED BY SERVICE THROUGH A REVIEW OF THE EVENT HISTORY. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS NOT IDENTIFIED AS THE CONDITION WAS NOT RELATED TO THE CUSTOMER REPORTED CONDITION. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR 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 TO HAVE EXPERIENCED A DOWNSTREAM OCCLUSION ALARM, WHICH INTERRUPTED DELIVERY. THIS ALARM MAY HAVE BEEN A FALSE ALARM. THERE IS NO KNOWN PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 5. 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