FDA Adverse Event Malfunction Summary report: N

COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

MDR report key: 1873185 · Received October 18, 2010

Report

Report Number: 6000001-2010-04177
Event Type: Malfunction
Date Received: October 18, 2010
Date of Event: August 14, 2010
Report Date: August 30, 2010
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FRN
Removal / Correction Number: 6000001-12/1/08-002-C
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). (B)(4).

Additional Manufacturer Narrative · 1

THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE CONDITION OF BATTERY ISSUE WAS CONFIRMED THROUGH AN ONSITE REPAIR. THE CONDITION IS DUE TO DEPLETED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED. (B)(4).

Description of Event or Problem · 1

DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A BATTERY DEPLETED ALARM WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.08.90 CATEGORIZED AS REMEDIATED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1