FDA Adverse Event Malfunction Summary report: N

COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

MDR report key: 1173646 · Received September 25, 2008

Report

Report Number: 6000001-2007-05449
Event Type: Malfunction
Date Received: September 25, 2008
Date of Event: March 1, 2007
Report Date: March 5, 2007
Manufacturer: BAXTER HEALTHCARE PTE. LTD.
Product Code: FRN
Removal / Correction Number: 2005-047-MD
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, 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 APR 04 2007. EVALUATION SUMMARY:DURING PRODUCT EVALUATION, A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS OBSERVED. FAILURE CODE 402:317:858:0000 IN THE EVENT HISTORY CONFIRMS THE DEFECTIVE UIM PCB. THIS FAILURE CODE IS MANIFESTED AS A RESULT OF THE UIM PCB BEING DEFECTIVE. THE UIM PCB WAS 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. THE FACILITY REPORTED THE INFUSION PUMP WITH A FAILURE CODE 402:317:858:0000.

Description of Event or Problem · 1

THE DEVICE WAS RETURNED TO BAXTER FOR SERVICE. DURING TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH A DEFECTIVE USER INTERFACE MECHANISM PRINTED CIRCUIT BOARD (UIM PCB). ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS KNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLLEAGUE 3 VOLUMETRIC INFUSION PUMP	INFUSION PUMP	FRN	BAXTER HEALTHCARE PTE. LTD.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1