MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-11-27 for ACCURA HEMOFILTRATION SYSTEM 5M5660 manufactured by Mesys.
[775751]
A customer contacted baxter's technical service center regarding an accura device,that removed too much fluid during a treatment. The patient had to be removed from the device and be placed on another unit for therapy. No patient injury was reported at the time of the initial call. Multiple attempts were made to obtain further information regarding the status of the patient, but all were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[8013749]
Evaluation summary: a field service engineer (fse) evaluated the device on site in 2007 and found no problems. The fse made no adjustments to the device. The voltages, pressures, pump delivery rates, scales, blood leak detector, temperature, air detector, and venous line clamp were tested and no problems were found. A simulated patient treatment was done using a filtrate collection of 2050ml. The actual collection was 2057ml, which is within acceptable accuracy limits. No problems were noted during the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2007-01233 |
| MDR Report Key | 958292 |
| Report Source | 04 |
| Date Received | 2007-11-27 |
| Date of Report | 2007-10-29 |
| Date of Event | 2007-10-29 |
| Date Mfgr Received | 2007-10-29 |
| Date Added to Maude | 2008-03-17 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY, MGR |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | MESYS |
| Manufacturer Street | BENECKEALLE 30 |
| Manufacturer City | HANNOVER 30419 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 30419 |
| 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 | 2007-11-27 |
| Returned To Mfg | 2007-10-30 |
| Model Number | NA |
| Catalog Number | 5M5660 |
| Lot Number | NA |
| ID 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 | 956685 |
| Manufacturer | MESYS |
| Manufacturer Address | HANOVER GM 30419 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-27 |