MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-04-14 for F70 HEMOFLOW DIALYZER 12/CS 0159707 manufactured by Fresenius.
[17108449]
Health care professional reporting an increase in blood leaks since february, when the facility began using f70nr dialyzer. This is the report of the first of five internal blood leaks. There were two lot numbers identified among the five complaints. The pt was initiated onto dialysis with the cobec3 dialysis machine. Two minutes later, blood was seen and detected in the dialysate effluent. Gross blood was evident. Accoridng to health care professional, not able to reinfuse blood, system of approximately 210 cc discarded. No pt (medical) intervention necessary. Complaint sample was discarded. Requested that any future samples be saved and to notify quality systems. Mdr filed due to blood loss reported. Unable to acquire further info regarding the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-1999-00125 |
| MDR Report Key | 219707 |
| Report Source | 05,06 |
| Date Received | 1999-04-14 |
| Date of Report | 1999-04-02 |
| Date of Event | 1999-02-20 |
| Date Reported to Mfgr | 1998-12-30 |
| Date Mfgr Received | 1999-03-31 |
| Device Manufacturer Date | 1998-12-01 |
| Date Added to Maude | 1999-04-22 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F70 HEMOFLOW DIALYZER 12/CS |
| Generic Name | SINGLE USE HIGH FLUX DIALYZER |
| Product Code | KJI |
| Date Received | 1999-04-14 |
| Model Number | NA |
| Catalog Number | 0159707 |
| Lot Number | 8N10208 |
| ID Number | 0500137N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 213072 |
| Manufacturer | FRESENIUS |
| Manufacturer Address | 475 WEST 13TH ST. OGDEN UT 84404 US |
| Baseline Brand Name | F70 HEMOFLOW DIALYZER 12/CS |
| Baseline Generic Name | HIGH FLOW DIALYZER |
| Baseline Model No | * |
| Baseline Catalog No | 0159707 |
| Baseline ID | 0500137N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2 | 1. Other | 1999-04-14 |