MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-17 for 2008K HEMODIALYSIS MACHINE UNK manufactured by Fresenius Medical Care;.
[18327424]
A pt undergoing hemodialysis therapy experienced separation of their venous blood line and central venous catheter that was not detected or signaled by the hemodialysis machine monitoring system. A large blood loss resulted. The pt expired soon after the event. Four (4) minutes prior to the event, the venous blood line/central venous catheter connection had been checked and found to be secure and with no evidence of leakage or loosening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 636939 |
| MDR Report Key | 636939 |
| Date Received | 2005-09-17 |
| Date of Report | 2005-09-17 |
| Date of Event | 2005-09-02 |
| Date Facility Aware | 2005-09-02 |
| Report Date | 2005-09-17 |
| Date Reported to FDA | 2005-09-17 |
| Date Reported to Mfgr | 2005-09-17 |
| Date Added to Maude | 2005-09-27 |
| 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 | 3 |
| 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 | 2008K HEMODIALYSIS MACHINE |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | FIL |
| Date Received | 2005-09-17 |
| Model Number | 2008K |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 626473 |
| Manufacturer | FRESENIUS MEDICAL CARE; |
| Manufacturer Address | 95 HAYDEN AVENUE LEXINGTON MA 02420 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. Death | 2005-09-17 |