FDA Adverse Event Malfunction Summary report: N

COLLEAGUE PRE P1.7

MDR report key: 2173459 · Received July 23, 2011

Report

Report Number: 6000001-2011-13546
Event Type: Malfunction
Date Received: July 23, 2011
Date of Event: April 22, 2011
Report Date: June 23, 2011
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FRN
PMA / PMN Number: K063696
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE SERVICED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN, AND THE CONDITION WAS CONFIRMED. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF MASTER COMPLAINT (B)(4). THE CAUSE IS UNKNOWN. NO REPAIRS WERE MADE TO CORRECT THE REPORTED CONDITION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS INVESTIGATED BY A BAXTER FIELD SERVICE ENGINEER 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.

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 13 OCCURRENCES OF A DOWNSTREAM OCCLUSION SET ALARM, WHICH INTERRUPTED DELIVERY. THESE ALARMS MAY HAVE BEEN FALSE ALARMS. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

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