MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-11 for ADVIA 2120I 067-A004 manufactured by Siemens Healthcare Diagnostics.
[17722056]
A siemens field service engineer (fse) was using a syringe to clear a clogged reagent line on an advia 2120i hematology system. The fse was not wearing safety glasses and hgb (hemoglobin) reagent splashed into his eye. The fse rinsed his eye with cold water several times. The fse also went to the emergency room for evaluation, where further eye rinsing and the application of eye drops and ointment took place. There was no known report of any other medical treatment.
Patient Sequence No: 1, Text Type: D, B5
[18017378]
The siemens field service engineer (fse) did not follow existing siemens procedures and safety precautions when handling the hazardous liquid ( hgb) reagent and the proper ppe was not used. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00163 |
| MDR Report Key | 2333497 |
| Report Source | 05,06 |
| Date Received | 2011-11-11 |
| Date of Report | 2011-10-14 |
| Date of Event | 2011-10-14 |
| Date Mfgr Received | 2011-10-14 |
| Date Added to Maude | 2011-11-14 |
| 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 | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED, CHAPEL LANE |
| Manufacturer City | SWORD, CO. DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120I |
| Generic Name | HEMATOLOGY ANALAYZER, PRODUCT CODE: |
| Product Code | GKL |
| Date Received | 2011-11-11 |
| Model Number | ADVIA 2120I |
| Catalog Number | 067-A004 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-11 |