BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VP 2000 PROCESSOR

    MDR report key: 4201285 · Received October 27, 2014

    Report

    Report Number
    3005248192-2014-00068
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KEY
    PMA / PMN Number
    510(K)EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 ELEVATED COMPLAINT INVESTIGATION 4224-ECINV CONCLUDES.

    Additional Manufacturer Narrative · 1

    THE ELEVATED COMPLAINT INVESTIGATION (B)(4) FOR MDR 3005248192-2014-00068 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 (02J11-01). PER A SERVICE HISTORY REVIEW, THE COMPLAINANT WATER BATHS WERE INSTALLED AFTER APRIL 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. 03N27-31 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 02J11-01. 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) 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.

    Description of Event or Problem · 1

    THE ABBOTT VP 2000 PROCESSOR IS A DEVICE DESIGNED TO AUTOMATE AND STANDARDIZE SLIDE SPECIMEN PROCESSING AND ROUTINE SLIDE STAINING FOR THE LABORATORY. DURING INSTALLATION OF A NEW INSTRUMENT AT A CUSTOMER SITE, THE FIELD SERVICE ENGINEER (FSE) OBSERVED WATER LEAKING FROM THE DRAIN FITTING OF THE WATER BASIN. THE FSE REPLACED THE WATER BATH. THE NEW WATER BATH IS OPERATING PER MANUFACTURE SPECIFICATIONS. NO INJURY WAS REPORTED. ELEVATED COMPLAINT INVESTIGATION 4224-ECINV IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682853 VP 2000 PROCESSOR STAINER, TISSUE, AUTOMATED KEY ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1