FDA Adverse Event Malfunction Summary report: N

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

MDR report key: 1173644 · Received September 25, 2008

Report

Report Number: 6000001-2007-05390
Event Type: Malfunction
Date Received: September 25, 2008
Date of Event: March 1, 2007
Report Date: March 6, 2007
Manufacturer: BAXTER HEALTHCARE PTE. LTD.
Product Code: FRN
Removal / Correction Number: CONTINUED IN H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, 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 02 2007. THE BAXTER FIELD SERVICE ENGINEER NOTED AN INFUSION PUMP WITH FAILURE CODE 403. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING A PATIENT INFUSION. EVALUATION SUMMARY: DURING PRODUCT EVALUATION, A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS OBSERVED. FAILURE CODE 403 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.

Description of Event or Problem · 1

THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE THE BAXTER REPAIR TECHNICIAN NOTED A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1