MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-19 for EVO-2 200 MCA 20020020 manufactured by Tecan Schweiz.
[4111445]
Laboratory called tecan on (b)(6) to report that during a test run of a evo 200 mca liquid handling pipettor instrument, the operator had pressed the pause button and reached inside the instrument to remove tips that were stuck to the mca head. The pause button was lit indicating instrument was paused. While the operator's hand was inside the instrument, the mca head moved down pinning the operator's hand to the deck of the instrument. The operator hit the pause button to unpause the instrument and the mca head moved up freeing the operator's hand. The operator sustained minor injury to the hand including a cut with bleeding. No medical treatment was required other than basic first aid. The test run was without reagents and the tips were clean and sterile. No risk of biohazard exposure.
Patient Sequence No: 1, Text Type: D, B5
[11355558]
A tecan field service engineer (fse) went to the laboratory to available the instrument. The laboratory had mechanically disabled the door locks on the instrument. When the door locks are engaged on the instrument and the pause button is pressed, the door locks will not open and not allow access until the instrument has completed all moves that are in process or already sent via a command. In this case, the pause button was pressed and the door locks were defeated allowing the operator to gain access prior to all of the moves being completed. This resulted in an injury to the instrument operator when they reached into the instrument to remove tips stuck to the mca pipetting head. The tecan fse reconfigured the door locks and ran diagnostic test. All safety tests passed including door locks, pause/resume function, and acoustic alarm. There was no malfunction. Tecan installs instruments with door locks enabled.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2013-00007 |
| MDR Report Key | 3505549 |
| Report Source | 05 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-11-01 |
| Date of Event | 2013-11-01 |
| Date Mfgr Received | 2013-11-04 |
| Date Added to Maude | 2013-12-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. ALEXANDER KRIEG |
| Manufacturer Street | 103 SEESTRASSE |
| Manufacturer City | MAENNEDORF ZUERICH |
| Manufacturer Country | SZ |
| Manufacturer Phone | 449228560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVO-2 200 MCA |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2013-11-19 |
| Catalog Number | 20020020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SCHWEIZ |
| Manufacturer Address | MAENNEDORF ZUERICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-19 |