FDA Adverse Event Malfunction Summary report: N

COLLEAGUE

MDR report key: 2250588 · Received September 16, 2011

Report

Report Number: 6000001-2011-25066
Event Type: Malfunction
Date Received: September 16, 2011
Date of Event: September 1, 2011
Report Date: September 7, 2011
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FRN
PMA / PMN Number: K063696
Removal / Correction Number: 6000001-12/1/08-002-C
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY ALARM WAS CONFIRMED DURING EVALUATION. THE CAUSE OF THE DAMAGED BATTERY WAS DETERMINED DUE TO BE USER ERROR. THE BATTERY AND BATTERY HARNESS WERE REPLACED TO FIX THE REPORTED CONDITION. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER'S INVESTIGATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS CONDITION WAS FOUND UPON POWER UP. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVED AND THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1