MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2010-08-20 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008H NA manufactured by Fresenius Medical Care North America.
[1588920]
A dialysis facility reported that there was excess fluid removed from a pt during a hemodialysis treatment. The pt became hypotensive, c/o cramping and was (b)(6). Below dry weight post dialysis, after receiving a total of 2,500 ml of saline. The machine gave an air detector alarm and a low flow error alarm. Dialysis treatment was resumed on another machine. Pt was discharged in stable condition but was cramping and felt weak at home for one day.
Patient Sequence No: 1, Text Type: D, B5
[8675378]
Air detector alarm and low flow error. Device was evaluated by facility. Valve 34 was replaced. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2010-00008 |
| MDR Report Key | 1816488 |
| Report Source | 00,05 |
| Date Received | 2010-08-20 |
| Date of Report | 2010-07-26 |
| Date of Event | 2010-07-15 |
| Date Facility Aware | 2010-07-15 |
| Report Date | 2010-07-23 |
| Date Reported to Mfgr | 2010-07-23 |
| Date Mfgr Received | 2010-07-23 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2010-12-28 |
| 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 | 3 |
| Manufacturer Contact | ELVY DIZON, BSN, RN, CNN |
| Manufacturer Street | 2637 SHADELANDS DR. |
| Manufacturer City | WALNUT CREEK CA 94598 |
| Manufacturer Country | US |
| Manufacturer Postal | 94598 |
| Manufacturer Phone | 9252950200 |
| Single Use | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS DIALYSIS DELIVERY SYSTEM |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | FKP |
| Date Received | 2010-08-20 |
| Model Number | 2008H |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | WALNUT CREEK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-20 |