FDA Adverse Event Malfunction Summary report: N

COLLEAGUE VOLUMETRIC INFUSION PUMP

MDR report key: 1832717 · Received September 13, 2010

Report

Report Number: 6000001-2007-01030
Event Type: Malfunction
Date Received: September 13, 2010
Date of Event: December 15, 2006
Report Date: December 15, 2006
Manufacturer: BAXTER HEALTHCARE PTE. LTD.
Product Code: FRN
Removal / Correction Number: CONTINUED ON H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NM, US
Reporter Occupation: OTHER

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 (B)(4) 2007. EVALUATION SUMMARY: THE REPORTED FAILURE CODE 570 FOUND IN THE EVENT HISTORY WAS CONFIRMED BY THE BAXTER REPAIR TECHNICIAN. INSPECTION OF THE DEVICE REVEALED DEPLETED MAIN BATTERIES WITH 17 DISCHARGES BELOW ALARM THRESHOLD. THE REPAIR TECHNICIAN REPLACED THE MAIN BATTERIES AND BATTERY HARNESS. THE DEVICE WAS TESTED AND RETURNED TO SERVICE. 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, MDQ-CAPA-132. 6000001-2/25/05-004-C, 6000001-12/13/05-019-C.

Description of Event or Problem · 1

THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH A FAILURE CODE 570 FOUND IN THE EVENT HISTORY. PER THE SERVICE SHOP, THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS KNOWN.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1