MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-18 for WALK AWAY 40 PLUS N/A B1018-283 manufactured by Beckman Coulter.
[31567217]
(b)(6). (b)(4). A second field service engineer (fse) completed the service of the instrument and reported that the air tubing was likely inadvertently swapped when the first fse replaced the reagent control board. The second fse explained that the swapped air tubing would cause the pressure on the solenoid valves to be 30-40psi, instead of 3. 0psi, as the air control valve would no longer controls the pressure, as it should when the lines are properly connected. The second fse pressurized the system, and found the (b)(4)'s reagent valve failed. Four other valves were observed to be leaking at the valve itself. The failed valves were likely due to the increased pressure on the solenoid valves due to the swapped air tubing. (b)(4)'s reagent is a biochemical reagent consisting of isoamyl alcohol, para-dimethylaminobenzaldehyde and hydrochloric acid. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31567218]
It was reported that a beckman coulter field service engineer (fse) was sprayed in the eyes with kovac's reagent while on site servicing the walkaway 40 plus instrument. The fse was not wearing safety glasses at the time. He went to the emergency room and was treated with saline eye wash, pain killers, and antibiotics. An ophthalmologist - cornea specialist diagnosed the injury as a burn to the cornea. In addition to the medications prescribed by the emergency room doctor, the fse was given steroids and asked to take vitamin c. After a follow-up appointment on (b)(6) 2015, the fse was cleared to return to work on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2015-00111 |
| MDR Report Key | 5234741 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-18 |
| Date of Report | 2015-10-21 |
| Date of Event | 2015-10-20 |
| Date Mfgr Received | 2015-10-20 |
| Device Manufacturer Date | 2008-08-05 |
| Date Added to Maude | 2015-11-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NORMA RAHILL |
| Manufacturer Street | 1584 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742139 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALK AWAY 40 PLUS |
| Generic Name | INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS |
| Product Code | LRG |
| Date Received | 2015-11-18 |
| Model Number | N/A |
| Catalog Number | B1018-283 |
| Lot Number | N/A |
| Operator | SERVICE AND TESTING PERSONNEL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-18 |