MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-07-12 for ADVIA 120 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[3652169]
The customer reported that hemoglobin reagent leaked out of a reagent pump on the advia 120 instrument, causing an electrical short that affected power to the customer lab. There were no injuries reported, no known reports of medical intervention or adverse health consequences and no known delay in patient testing due to the leaking reagent pump.
Patient Sequence No: 1, Text Type: D, B5
[10997044]
A siemens healthcare diagnostics field service engineer (fse) was dispatched to the customer site for instrument evaluation. After evaluating the instrument, the fse determined that the cause for the hemoglobin reagent leak was due to a malfunction in the reagent pump membrane. The fse replaced the reagent pump and electrical components affected by the leak. The analyzer is operating according to specifications. No further evaluation of the analyzer is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00320 |
| MDR Report Key | 3222877 |
| Report Source | 01,05,06 |
| Date Received | 2013-07-12 |
| Date of Report | 2013-06-19 |
| Date of Event | 2013-06-13 |
| Date Mfgr Received | 2013-06-19 |
| Device Manufacturer Date | 2003-03-22 |
| Date Added to Maude | 2013-10-03 |
| 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 | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | CHAPEL LANE SWORDS |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2013-07-12 |
| Model Number | ADVIA 120 |
| Catalog Number | 067-A004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-12 |