MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-11-12 for VP 2000 PROCESSOR 02J11-01 manufactured by Abbott Molecular, Inc..
[5048600]
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 reported that both the front and back hoods on two vp2000 instruments have cracked. The cracks first appeared approximately two weeks after the instruments were installed and progressed with time. An abbott field service engineer (fse) replaced the front hood and rear hood of each instrument and verified that the hoods opened and closed properly. No death or injury was reported. Although a product malfunction has not been confirmed, the cracks in the hood have the potential to expose the user to sharp edges and potential user injury such as cuts or abrasions. Because the hoods are used to cover slides containing biohazardous materials and because the hood material itself may have remnants of biohazardous materials on its surface, there is potential for the user to sustain a serious injury from a sharp edge of the cracked hood and to require further treatment because of exposure to biohazardous materials. This incident is reported based on the potential for serious injury. Elevated complaint investigation (b)(4) is in process.
Patient Sequence No: 1, Text Type: D, B5
[12553057]
Attached photos show the cracks in the hood. Because the reported incident occurred with two vp2000 instruments, a separate mdr 3005248192-214-00073 was also submitted on (b)(4) 2014 for the first device. Follow-up mdr reports will be submitted after elevated complaint investigation 4265-ecinv concludes.
Patient Sequence No: 1, Text Type: N, H10
[33864347]
Summary of (b)(4) for mdr 3005248192-2014-00073 follow-up report 1: note: a separate form 3500a (mdr 3005248192-2014-00073 follow-up report 1) was completed for a second vp2000 device (serial number (b)(4)) reported at the same customer site. The following elevated complaint investigation summary includes both devices. Investigation into this complaint included: quality data review, return evaluation and complaint history review. Existing data review: pictures attached in each complaint were reviewed to identify correlation to the information provided within the complaints "activity" tab. Multiple cracks could be seen on the hoods of these instruments in the attached pictures. The vp2000 processor operations manual (30-608384, revc - january 2009) was reviewed to identify instructions for using the instrument hoods. Quality data review: device history record / batch record review: the manufacturing batch record for the vp2000 processor, part 30-144101, lot number 449679, (serial number (b)(4)) and lot number 449660 (serial number (b)(4)) were reviewed. Both batch records indicated these instruments were manufactured and tested according to applicable procedures and were approved to inventory on 10/28/2013. Capa / non-conformance review: a nonconformance and capa investigation search was performed. Per the search results, 1 product nonconformance and 4 capas were identified, however, none of these were found to be related to vp2000 hoods being cracked. Product/system/instrument evaluation: retain / file sample evaluation: retain testing was not completed since vp2000 processor (30-144100) and spare parts (30-144311, 30-144194, 30-144195) are not retained. Return sample evaluation: customer vp2000 processor hood parts 30-144194 and 30-144195 were returned and evaluated. A sharpness test was performed and identified these cracks would not cause an instrument operator to suffer a laceration from incidental contact with these parts. Complaint history review: (b)(4). Product deficiency decision: per md13255, v4, section 1. 5 a defined user need for the vp2000 processor is "users need the system that does not expose the operator to electrical, physical, and biological hazards. " a sharpness test was performed as part of this investigation, which confirmed that the cracks would not present a danger of laceration by incidental contact to an instrument operator. The frequency of occurrence for cracked vp2000 processor hoods while in use at the customer site was found to be 1. 56% and therefore the overall frequency for this type of error is low relative to the number of possible occurrences. Since there is not a present danger of laceration, the frequency of occurrence 1. 56%, and these parts are within the current reliability rate threshold, there is no product deficiency for this investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2014-00074 |
| MDR Report Key | 4247010 |
| Report Source | 07 |
| Date Received | 2014-11-12 |
| Date of Report | 2014-10-17 |
| Date of Event | 2014-03-07 |
| Date Mfgr Received | 2015-01-08 |
| Date Added to Maude | 2014-11-25 |
| 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 | 2014-11-12 |
| Catalog Number | 02J11-01 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-11-12 |