MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-01 for POLYSULFONE HEMODIALYZER F80A NA manufactured by Fresenius Medical Care.
[301076]
Pt being treated with reused hemodialyzer experienced shaking, chills and vomiting, beginning 1-1/2 hours after initiating hemodialysis therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 469436 |
| MDR Report Key | 469436 |
| Date Received | 2003-07-01 |
| Date of Report | 2003-06-20 |
| Date of Event | 2003-04-17 |
| Date Facility Aware | 2003-04-17 |
| Report Date | 2003-06-20 |
| Date Reported to Mfgr | 2003-06-23 |
| Date Added to Maude | 2003-07-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYSULFONE HEMODIALYZER |
| Generic Name | HEMODIALYZER |
| Product Code | KDI |
| Date Received | 2003-07-01 |
| Model Number | F80A |
| Catalog Number | NA |
| Lot Number | 2KU207 (F80A) |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 458300 |
| Manufacturer | FRESENIUS MEDICAL CARE |
| Manufacturer Address | 95 HAYDEN AVE LEXINGTON MA 02420 US |
| Baseline Brand Name | FRESENIUS HEMOFLOW DIALYZER |
| Baseline Generic Name | HOLLOW FIBER DIALYZER |
| Baseline Model No | F80A |
| Baseline Catalog No | 0500154A |
| Baseline ID | 0159822 |
| Baseline Device Family | HIGH FLUX DIALYZER |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K926006 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Brand Name | RENATRON |
| Generic Name | REPROCESSING DEVICE |
| Product Code | LIF |
| Date Received | 2003-07-01 |
| Model Number | RS8330 |
| Catalog Number | NA |
| Lot Number | * |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 2 |
| Device Event Key | 458302 |
| Manufacturer | MINNTECH CORP |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-01 |