MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-30 for VP 2000 PROCESSOR 02J11-001 manufactured by Abbott Molecular, Inc..
[3094540]
The abbott vp 2000 processor is a device designed to automate and standardize slide specimen processing and routine slide staining for the laboratory. Customer reported having a leaking basin. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[10232764]
Abbott molecular inc. Is aware of the problem with the vp 2000 processor basins. An urgent product recall [z-2313-2010] 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 recall was concluded in the united states in october, 2010; all leaking basins were replaced all non-leaking basins were inspected by abbott field service personnel. Based on this add'l complaint, another urgent product recall was issued fa cam-dec2010-093. This recall will coordinate replacement of all vp 2000 heater basins impacted by this mfg issue. The following mdrs were also filed: mdr 3005248192-2010-0002, filed on (b)(4) 2010; 0005, 0006 filed on (b)(4) 2010; 0007, 0008 filed on (b)(4) 2010, 0011 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 min < 100 ul per min. When 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 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
| Report Number | 3005248192-2010-00012 |
| MDR Report Key | 2796733 |
| Report Source | 07 |
| Date Received | 2010-12-30 |
| Date of Report | 2010-12-30 |
| Date of Event | 2010-11-29 |
| Date Mfgr Received | 2010-11-29 |
| Date Added to Maude | 2012-10-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DIMITRIS DEMIRTZOGLOU |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617975 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VP 2000 PROCESSOR |
| Generic Name | STAINER, TISSUE, AUTOMATED |
| Product Code | KEY |
| Date Received | 2010-12-30 |
| Model Number | 02J11-001 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-30 |