FDA Adverse Event Malfunction Summary report: N

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

MDR report key: 1160149 · Received September 16, 2008

Report

Report Number: 6000001-2007-00624
Event Type: Malfunction
Date Received: September 16, 2008
Date of Event: December 1, 2006
Report Date: December 11, 2006
Manufacturer: BAXTER HEALTHCARE PTE. LTD.
Product Code: FRN
Removal / Correction Number: CONTINUED ON H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 05 2007. EVALUATION SUMMARY:EVALUATION OCCURRED ON-SITE. FAILURE CODE 570 WAS CONFIRMED IN THE EVENT HISTORY. FAILURE CODE 570 IS CAUSED BY LOW BATTERY VOLTAGE. INSPECTION OF THE DEVICE FOUND THAT THE PUMP'S BATTERIES HAD 91 BATTERY DISCHARGES BELOW THE ALARM THRESHOLD WHICH INDICATED THAT THE PUMP'S BATTERIES WERE DAMAGED. THE BATTERIES WERE THEREFORE REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

Description of Event or Problem · 1

A BAXTER FIELD SERVICE ENGINEER REPORTED AN INFUSION PUMP WITH FAILURE CODE 570. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLLEAGUE CX VOLUMETRIC INFUSION PUMP	INFUSION PUMP	FRN	BAXTER HEALTHCARE PTE. LTD.	N/A	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1