MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-19 for ACCURA HEMOFILTRATION SYSTEM 5M5660 manufactured by Mesys Gmbh- Medizinische Systeme.
[857162]
A biomed at the facility called baxter technical service regarding an accura hemodialysis instrument. The instrument is removing too much fluid. No pt injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
[8000724]
A field service engineer (fse) went to the facility and determined the scales were out of calibration. The fse calibrated both scales. Machine was tested according to the accura data test sheet. No other problems were noted. The instrument is fully functional. A follow up call was placed to the facility by baxter corporate product surveillance. The biomed was asked if this incident occurred during pt use. He stated a measurement was taken after the pt treatment. He also stated that he did not have any details about the incident other than there was no pt injury and no medical intervention. The biomed was unable to provide further details. The biomed also was unable to identify a clinical contact. No further info was able to be obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00374 |
| MDR Report Key | 1048085 |
| Report Source | 05 |
| Date Received | 2008-05-19 |
| Date of Report | 2008-04-21 |
| Date of Event | 2008-04-21 |
| Date Mfgr Received | 2008-04-21 |
| Date Added to Maude | 2008-07-17 |
| 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 | KAREN KIRBY, MGR |
| Manufacturer Street | 25212 W. ILLINOIS RTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | MESYS GMBH-MEDIZINISCHE SYSTEME |
| Manufacturer Street | PLATHNERSTRASSE, 5B |
| Manufacturer City | HANNOVER 30175 |
| Manufacturer Postal Code | 30175 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCURA HEMOFILTRATION SYSTEM |
| Generic Name | 78FIR |
| Product Code | FIR |
| Date Received | 2008-05-19 |
| Catalog Number | 5M5660 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1043028 |
| Manufacturer | MESYS GMBH- MEDIZINISCHE SYSTEME |
| Manufacturer Address | HANNOVER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-19 |