MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-04-18 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008K NA manufactured by Fresenius Medical Care-north America.
[15606628]
These are two of the events reported in a previously submitted medwatch report (00023). Additional information was received on 4/2002. This patient was dialyzed on the same machine and admitted to the hospital twice for similar problems. At the end of a hemodialysis treatment, the patient became hypotensive, incoherent, weak and unable to stand. Patient was given a total of 950 cc. Of saline. The machine indicated that 1,000 ml. Was removed. Patient was discharged home but was later taken to the hospital by the family.
Patient Sequence No: 1, Text Type: D, B5
[15840509]
At the end of a hemodialysis treatment, the patient became incoherent, weak and sluggish. Patient's blood sugar was 126. Patient was given a total of 1,050 cc. Of saline. The machine was set to remove 300 ml. And it indicated that 300 ml. Was removed. Patient's pre weight was 62. 9 kg. Post weight was not taken since patient was too weak to stand. Patient was transported to the hospital by ems. Reason for admission was believed to be related to excessive fluid removed.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 2937457-2002-00027 |
| MDR Report Key | 389819 |
| Report Source | 05 |
| Date Received | 2002-04-18 |
| Date of Report | 2002-02-20 |
| Date of Event | 2002-02-08 |
| Report Date | 2002-02-20 |
| Date Reported to Mfgr | 2002-02-20 |
| Date Mfgr Received | 2002-02-20 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2002-04-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELVY DIZON, BSN, RN, CNN |
| Manufacturer Street | 2637 SHADELANDS DRIVE |
| Manufacturer City | WALNUT CREEK CA 94598 |
| Manufacturer Country | US |
| Manufacturer Postal | 94598 |
| Manufacturer Phone | 9252950200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS DIALYSIS DELIVERY SYSTEM |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | FIL |
| Date Received | 2002-04-18 |
| Model Number | 2008K |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 378866 |
| Manufacturer | FRESENIUS MEDICAL CARE-NORTH AMERICA |
| Manufacturer Address | 2637 SHADELANDS DR. WALNUT CREEK CA 94598 US |
| Baseline Brand Name | FRESENIUS DIALYSIS DELIVERY SYSTEM |
| Baseline Generic Name | HEMODIALYSIS MACHINE |
| Baseline Model No | 2008K |
| Baseline Catalog No | F002-40 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K994267 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2002-04-18 |
| 2 | 0 | 1. Hospitalization | 2002-04-18 |