MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-17 for VP 2000 PROCESSOR 02J11-01 manufactured by Abbott Molecular, Inc..
[26487154]
An mdr follow-up report will be submitted after an elevated complaint investigation concludes.
Patient Sequence No: 1, Text Type: N, H10
[26487155]
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 which resolved the leakage issue. No injury was reported. 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 has the potential to cause serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
[32800888]
Investigation into this complaint for mdr 3005248192-2015-00019 follow-up report 1 included an existing data review, quality data review, a product/system/instrument evaluation, and a complaint history review. Existing data review: the abbott vp 2000 processor service manual (30-608308/r1 (b)(4) 2008) contains instructions for replacement of the rinse tank assembly. Quality data review (device history review): capa / non-conformance review: a nonconformance and capa investigation search was performed for the rinse tank assembly. There were 0 related nonconformances or capa investigation identified per the search results. Product/system/instrument evaluation: service history review: it was identified that this occurrence is the first replacement of the rinse tank assembly for the subject instrument. Complaint history review: a complaint search identified eight additional complaint related to leaking of the rinse tank assembly at the drain fitting. Three of the complaints were investigated and confirmed and three were addressed per risk assessment. Two complaints were closed to troubleshooting. Product deficiency decision based on the results of the investigation elements a product deficiency for rinse tank assembly on the vp2000 instrument was not identified. Therefore, this complaint will be dispositioned as unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2015-00019 |
| MDR Report Key | 5085913 |
| Date Received | 2015-09-17 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-09-07 |
| Date Mfgr Received | 2015-10-08 |
| Date Added to Maude | 2015-09-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEAN LEETE |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| 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 | 2015-09-17 |
| Catalog Number | 02J11-01 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-17 |