VP 2000 PROCESSOR

Additional Manufacturer Narrative

THE ELEVATED COMPLAINT INVESTIGATION (B)(4) FOR MDR 3005248192-2014-00061 INCLUDED PRODUCT EVALUATION (CUSTOMER DATA REVIEW, INSTALLATION/SERVICE HISTORY REVIEW AND SUPPLIER INFORMATION), QUALITY DATA REVIEW (NONCONFORMANCE REVIEW AND LABELING) AND A COMPLAINT SEARCH. THE INVESTIGATION IS SUMMARIZED BELOW: IMAGES ATTACHED TO THE COMPLAINTS WERE REVIEWED. THESE IMAGES VERIFIED THE PRESENCE OF A BROKEN AND /OR LEAKING WATER BATH ON THE VP2000 PROCESSOR ((B)(4)). PER A SERVICE HISTORY REVIEW, THE COMPLAINANT WATER BATHS WERE INSTALLED AFTER (B)(6) 2014. THE SUPPLIER OF VP2000 PROCESSOR WAS CONTACTED AND INDICATED THAT NOTHING HAD CHANGED IN MANUFACTURING OR SUPPLIERS TO CAUSE THE INCREASED NUMBER OF COMPLAINTS FOR THE WATER BATH. THE ABBOTT VP2000 PROCESSOR OPERATIONS MANUAL 30-608384 REV C-JANUARY 2009 LIST NO. (B)(4) WAS REVIEWED AND DETERMINED TO CONTAIN ADEQUATE INSTRUCTIONS IN REGARD TO CONNECTING DRAIN TUBING ONTO THE BARBED DRAIN FITTING ATTACHED TO THE WATER BATH. IT ALSO PROVIDES INSTRUCTIONS TO DRAIN THE WATER BATH BY REMOVING THE STANDPIPE ON THE DRAIN FITTINGS AS WEEKLY MAINTENANCE. A NON-CONFORMANCE REVIEW WAS PERFORMED FOR THE VP2000 PROCESSOR, LIST NUMBER (B)(4). REVIEW OF THE SEARCH RESULTS DID NOT REVEAL ANY ISSUES RELATED TO WATER BATH. COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST TWO YEARS, THE FOUR INVESTIGATED COMPLAINTS (B)(4) AND ONE ADDITIONAL COMPLAINT (B)(4) WERE FOUND TO BE RELATED TO BROKEN AND/ OR LEAKING RINSE TANK ASSEMBLIES PART NUMBER: 30-144175 ASSOCIATED WITH THE DRAIN FITTING ON THE VP2000 PROCESSOR. PRODUCT DEFICIENCY DECISION: BASED ON THIS INVESTIGATION, A PRODUCT DEFICIENCY HAS BEEN IDENTIFIED FOR THE RINSE TANK ASSEMBLY (PART NUMBER: 30-144175) ON THE VP2000 PROCESSOR. SINCE ALL VP2000 PROCESSOR VERSIONS USE THE SAME WATER BATH, VP2000 PROCESSOR 100V, 117V, AND 230V ARE AFFECTED. THIS INVESTIGATION HAS DETERMINED THAT THIS PART CAN LEAK DEIONIZED WATER. MEDICAL EVALUATION CONCLUDED THAT A MALFUNCTION DID OCCUR, BUT IF IT WERE TO RECUR, IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH.

Additional Manufacturer Narrative

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 MAY LEAD TO COMPLICATED FRACTURES CAUSING PERMANENT INJURY. A FOLLOW-UP MDR 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 AND RESTORED THE INSTRUMENT TO ITS FULLY OPERATIONAL CONDITION. NO INJURY WAS REPORTED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT DUE TO A DELAY IN RESULTS.