VP 2000 PROCESSOR
Received Sep 17, 2015
Report 3005248192-2015-00019 · MDR key 5085913
Device
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AN MDR FOLLOW-UP REPORT WILL BE SUBMITTED AFTER AN ELEVATED COMPLAINT INVESTIGATION CONCLUDES.
Description of Event or Problem
THE ABBOTT VP 2000 PROCESSOR IS A DEVICE DESIGNED TO AUTOMATE AND STANDARDIZE SLIDE SPECIMEN PROCESSING AND ROUTINE SLIDE STAINING FOR THE LABORATORY. THE CUSTOMER REPORTED A SLOW SMALL LEAK FROM A DRAIN FITTING OF THE WATER BASIN. THE FSE REPLACED THE RINSE TANK ASSEMBLY WHICH RESOLVED THE LEAKAGE ISSUE. NO INJURY WAS REPORTED. THIS MEDICAL DEVICE REPORT (MDR) IS SUBMITTED ON THE BASIS FOR POTENTIAL HARM SHOULD THE MALFUNCTION RECUR. WATER LEAKING ON THE FLOOR HAS THE POTENTIAL TO CREATE A SLIPPERY FLOOR SURFACE WITH AN ASSOCIATED HARM OF SLIPPING OR FALLING. SLIPPING AND/OR FALLING HAS THE POTENTIAL TO CAUSE SERIOUS INJURY OR DEATH .
Additional Manufacturer Narrative
INVESTIGATION INTO THIS COMPLAINT FOR MDR 3005248192-2015-00019 FOLLOW-UP REPORT 1 INCLUDED AN EXISTING DATA REVIEW, QUALITY DATA REVIEW, A PRODUCT/SYSTEM/INSTRUMENT EVALUATION, AND A COMPLAINT HISTORY REVIEW. EXISTING DATA REVIEW: THE ABBOTT VP 2000 PROCESSOR SERVICE MANUAL (30-608308/R1 (B)(4) 2008) CONTAINS INSTRUCTIONS FOR REPLACEMENT OF THE RINSE TANK ASSEMBLY. QUALITY DATA REVIEW (DEVICE HISTORY REVIEW): CAPA / NON-CONFORMANCE REVIEW: A NONCONFORMANCE AND CAPA INVESTIGATION SEARCH WAS PERFORMED FOR THE RINSE TANK ASSEMBLY. THERE WERE 0 RELATED NONCONFORMANCES OR CAPA INVESTIGATION IDENTIFIED PER THE SEARCH RESULTS. PRODUCT/SYSTEM/INSTRUMENT EVALUATION: SERVICE HISTORY REVIEW: IT WAS IDENTIFIED THAT THIS OCCURRENCE IS THE FIRST REPLACEMENT OF THE RINSE TANK ASSEMBLY FOR THE SUBJECT INSTRUMENT. COMPLAINT HISTORY REVIEW: A COMPLAINT SEARCH IDENTIFIED EIGHT ADDITIONAL COMPLAINT RELATED TO LEAKING OF THE RINSE TANK ASSEMBLY AT THE DRAIN FITTING. THREE OF THE COMPLAINTS WERE INVESTIGATED AND CONFIRMED AND THREE WERE ADDRESSED PER RISK ASSESSMENT. TWO COMPLAINTS WERE CLOSED TO TROUBLESHOOTING. PRODUCT DEFICIENCY DECISION BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS A PRODUCT DEFICIENCY FOR RINSE TANK ASSEMBLY ON THE VP2000 INSTRUMENT WAS NOT IDENTIFIED. THEREFORE, THIS COMPLAINT WILL BE DISPOSITIONED AS UNCONFIRMED.