MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-03 for VP 2000 PROCESSOR 02J11-001 manufactured by Abbott Molecular, Inc..
[4948380]
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 and restored the instrument to its fully operational condition. No injury was reported. There was no report of impact to patient management due to a delay in results.
Patient Sequence No: 1, Text Type: D, B5
[12248405]
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 an elevated complaint investigation concludes.
Patient Sequence No: 1, Text Type: N, H10
[37753106]
The elevated complaint investigation (b)(4) for mdr 3005248192-2014-00061 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 ((b)(4)). Per a service history review, the complainant water baths were installed after (b)(6) 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. (b)(4) 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 (b)(4). 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) and one additional complaint (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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2014-00061 |
| MDR Report Key | 4141357 |
| Report Source | 07 |
| Date Received | 2014-10-03 |
| Date of Report | 2014-09-05 |
| Date of Event | 2014-09-05 |
| Date Mfgr Received | 2014-11-04 |
| Date Added to Maude | 2014-10-16 |
| 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 | 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 60018331 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 3315 |
| 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 | 2014-10-03 |
| Catalog Number | 02J11-001 |
| Device Availability | N |
| 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 60018331 US 60018 3315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-03 |