MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-03-22 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008K NA manufactured by Fresenius Medical Care-north America.
[247258]
This is a supplemental report to a previously submitted medwatch. Initial report stated five pts were taken to the hosp. Info received today indicates that there were four hosp admissions (three pts) for possible ultrafiltraion (uf) problems. One pt was admitted twice. One pt c/o chest pain and became hypotensive during hemodialysis treatment. He was given 1,500 cc. Of saline and was taken to the er via ambulance. He was weighed upon admission and his weight showed that he was 2 kg. Below his dry weight of 26. 4 kg.
Patient Sequence No: 1, Text Type: D, B5
[280183]
A dialysis facility reported that five pts were taken to the hosp for vomiting, chest pains, hypotension and dehydration. It is believed that these symptoms were related to excessive fluid removed during hemodialysis treatments. It was reported that the pts lost 1-2kg. More than desired.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2937457-2002-00023 |
MDR Report Key | 383998 |
Report Source | 00 |
Date Received | 2002-03-22 |
Date of Report | 2002-02-20 |
Date of Event | 2002-02-18 |
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 | 2002-03-26 |
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 | 2002-03-22 |
Model Number | 2008K |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | 1 YR |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 373045 |
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 | 2002-03-22 |