VP 2000 PROCESSOR

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. A CUSTOMER REPORTED THAT BOTH THE FRONT AND BACK HOODS ON TWO VP2000 INSTRUMENTS HAVE CRACKED. THE CRACKS FIRST APPEARED APPROXIMATELY TWO WEEKS AFTER THE INSTRUMENTS WERE INSTALLED AND PROGRESSED WITH TIME. AN ABBOTT FIELD SERVICE ENGINEER (FSE) REPLACED THE FRONT HOOD AND REAR HOOD OF EACH INSTRUMENT AND VERIFIED THAT THE HOODS OPENED AND CLOSED PROPERLY. NO DEATH OR INJURY WAS REPORTED. ALTHOUGH A PRODUCT MALFUNCTION HAS NOT BEEN CONFIRMED, THE CRACKS IN THE HOOD HAVE THE POTENTIAL TO EXPOSE THE USER TO SHARP EDGES AND POTENTIAL USER INJURY SUCH AS CUTS OR ABRASIONS. BECAUSE THE HOODS ARE USED TO COVER SLIDES CONTAINING BIOHAZARDOUS MATERIALS AND BECAUSE THE HOOD MATERIAL ITSELF MAY HAVE REMNANTS OF BIOHAZARDOUS MATERIALS ON ITS SURFACE, THERE IS POTENTIAL FOR THE USER TO SUSTAIN A SERIOUS INJURY FROM A SHARP EDGE OF THE CRACKED HOOD AND TO REQUIRE FURTHER TREATMENT BECAUSE OF EXPOSURE TO BIOHAZARDOUS MATERIALS. THIS INCIDENT IS REPORTED BASED ON THE POTENTIAL FOR SERIOUS INJURY. ELEVATED COMPLAINT INVESTIGATION (B)(4) IS IN PROCESS.

Additional Manufacturer Narrative

ATTACHED PHOTOS SHOW THE CRACKS IN THE HOOD. BECAUSE THE REPORTED INCIDENT OCCURRED WITH TWO VP2000 INSTRUMENTS, A SEPARATE MDR 3005248192-214-00074 WILL BE FILED FOR THE SECOND DEVICE. FOLLOW-UP MDR REPORTS WILL BE SUBMITTED AFTER ELEVATED COMPLAINT INVESTIGATION 4265-ECINV CONCLUDES. (B)(4).

Additional Manufacturer Narrative

SUMMARY OF (B)(4) FOR MDR 3005248192-2014-00073 FOLLOW-UP REPORT 1: NOTE: A SEPARATE FORM 3500A (MDR 3005248192-2014-00074 FOLLOW-UP REPORT 1) WAS COMPLETED FOR A SECOND VP2000 DEVICE (SERIAL NUMBER (B)(4)) REPORTED AT THE SAME CUSTOMER SITE. THE FOLLOWING ELEVATED COMPLAINT INVESTIGATION SUMMARY INCLUDES BOTH DEVICES. INVESTIGATION INTO THIS COMPLAINT INCLUDED: QUALITY DATA REVIEW, RETURN EVALUATION AND COMPLAINT HISTORY REVIEW. EXISTING DATA REVIEW PICTURES ATTACHED IN EACH COMPLAINT WERE REVIEWED TO IDENTIFY CORRELATION TO THE INFORMATION PROVIDED WITHIN THE COMPLAINTS "ACTIVITY" TAB. MULTIPLE CRACKS COULD BE SEEN ON THE HOODS OF THESE INSTRUMENTS IN THE ATTACHED PICTURES. THE VP2000 PROCESSOR OPERATIONS MANUAL (30-608384, REVC - JANUARY 2009) WAS REVIEWED TO IDENTIFY INSTRUCTIONS FOR USING THE INSTRUMENT HOODS. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW THE MANUFACTURING BATCH RECORD FOR THE VP2000 PROCESSOR, PART 30-144101, LOT NUMBER 449679, (SERIAL NUMBER (B)(4)) AND LOT NUMBER 449660 (SERIAL NUMBER (B)(4)) WERE REVIEWED. BOTH BATCH RECORDS INDICATED THESE INSTRUMENTS WERE MANUFACTURED AND TESTED ACCORDING TO APPLICABLE PROCEDURES AND WERE APPROVED TO INVENTORY ON 10/28/2013. CAPA / NON-CONFORMANCE REVIEW A NONCONFORMANCE AND CAPA INVESTIGATION SEARCH WAS PERFORMED. PER THE SEARCH RESULTS, 1 PRODUCT NONCONFORMANCE AND 4 CAPAS WERE IDENTIFIED, HOWEVER, NONE OF THESE WERE FOUND TO BE RELATED TO VP2000 HOODS BEING CRACKED. PRODUCT/SYSTEM/INSTRUMENT EVALUATION: RETAIN / FILE SAMPLE EVALUATION RETAIN TESTING WAS NOT COMPLETED SINCE VP2000 PROCESSOR (30-144100) AND SPARE PARTS (30-144311, 30-144194, 30-144195) ARE NOT RETAINED. RETURN SAMPLE EVALUATION: CUSTOMER VP2000 PROCESSOR HOOD PARTS 30-144194 AND 30-144195 WERE RETURNED AND EVALUATED. A SHARPNESS TEST WAS PERFORMED AND IDENTIFIED THESE CRACKS WOULD NOT CAUSE AN INSTRUMENT OPERATOR TO SUFFER A LACERATION FROM INCIDENTAL CONTACT WITH THESE PARTS. COMPLAINT HISTORY REVIEW: A COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY ADDITIONAL COMPLAINTS RELATED TO CRACKED HOODS ON THE VP2000 PROCESSOR. (B)(4). PRODUCT DEFICIENCY DECISION PER MD13255, V4, SECTION 1.5 A DEFINED USER NEED FOR THE VP2000 PROCESSOR IS "USERS NEED THE SYSTEM THAT DOES NOT EXPOSE THE OPERATOR TO ELECTRICAL, PHYSICAL, AND BIOLOGICAL HAZARDS." A SHARPNESS TEST WAS PERFORMED AS PART OF THIS INVESTIGATION, WHICH CONFIRMED THAT THE CRACKS WOULD NOT PRESENT A DANGER OF LACERATION BY INCIDENTAL CONTACT TO AN INSTRUMENT OPERATOR. (B)(4).