FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 2M8063
Received Nov 13, 2008 · Event occurred Jun 26, 2007
Report 6000001-2007-88929 · MDR key 1226823
Device
Generic name
80frn
Manufacturer
Baxter Healthcare (sg)Model number
BAXTER HEALTHCARE (SG)Catalog number
2M8063R
Lot number
C
Product problems
- Component(s), broken
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, A BROKEN DOOR ASSEMBLY WAS FOUND. ACCORDING TO THE FACILITY REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.
Additional Manufacturer Narrative
THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 20, 2007. EVALUATION SUMMARY: A BAXTER SERVICE TECHNICIAN EVALUATED THE PUMP. THE REPORTED CONDITION WAS CONFIRMED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED.