VP 2000 PROCESSOR 02J11-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-17 for VP 2000 PROCESSOR 02J11-001 manufactured by Abbott Molecular, Inc..

Event Text Entries

[3085881] 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 in (b)(6), responding to the product action fa-cam-jul 2010-085, reported having a leaking basin. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[10238936] Abbott molecular inc, is aware of the problem with the vp 2000 processor basins. An urgent product recall (3005248192-06/18/2010-001-c), was distributed via (b)(4) shipment to united states customers, based on customer receipt of vp 2000 processor and basin spare part since (b)(4) 2008. The following mdrs were also filed: mdr 3005248192-2010-0002, filed on (b)(4) 2010. Mdr 3005248192-2010-0005, filed on (b)(4) 2010. Mdr 3005248192-2010-0006, filed on (b)(4) 2010. Mdr 3005248192-2010-0007, filed on (b)(4) 2010. Mdr 3005248192-2010-0008, filed on (b)(4) 2010. Three potential hazards were identified: delay in results. There is no harm associated with this hazard. Chemical exposure. There is no harm associated with this hazard as this issue does not increase the already expected exposure to these reagents. Therefore, there is no introduced operator harm. Slip hazard. Eval determined that the overall health risk was low, based on the following: the overall estimate for a leaking basin was (b)(4) (based on basins known to be related to this issue). Leaking rate is expected to be about 1 to 2 drops per minute < 100 ul per min. ). Then a loaded basin is either used in the vp2000 or stored on the lab bench, in the typical usage time < 8 hours), the leaked liquid will be less than 50 ml. Slip hazard will be avoided by the operator's observance of the liquid on the floor and by the small volume of liquid. If a leak were to occur, it would occur in an area that a lab operator would not normally walk (in the vp2000) or during reagent addition (lab bench). In addition, the leak would be visually obvious to the operator. If the operator did step on the leak, it would not necessarily lead to a fall that would lead to a serious injury.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005248192-2010-00011
MDR Report Key2796724
Report Source07
Date Received2010-12-17
Date of Report2010-12-17
Date of Event2010-11-19
Date Mfgr Received2010-11-19
Date Added to Maude2012-10-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR DIMITRIS DEMIRTZOGLOU
Manufacturer Street1300 EAST TOUHY AVENUE
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal60018
Manufacturer Phone2243617975
Manufacturer G1ABBOTT MOLECULAR, INC.
Manufacturer Street1300 EAST TOUHY AVENUE
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal Code60018
Single Use3
Remedial ActionRL
Previous Use Code3
Removal Correction Number3005248192-06/18/2010-00
Event Type3
Type of Report3

Device Details

Brand NameVP 2000 PROCESSOR
Generic NameSTAINER, TISSUE, AUTOMATED, PRODUCT CODE: KEY
Product CodeKEY
Date Received2010-12-17
Catalog Number02J11-001
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MOLECULAR, INC.
Manufacturer Address1300 E TOUHY AVENUE DES PLAINES IL 60018 US 60018


Patients

Patient NumberTreatmentOutcomeDate
10 2010-12-17

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