MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-12-16 for FRESENIUS 2008K@HOME manufactured by Fresenius Medical Care North America.
[34076402]
No parts were not returned to the manufacturer for physical evaluation and the plant investigation is on-going. A supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[34076403]
A correspondence letter was received from the pt's caregiver which indicated the pt was deceased. No details, including the reporters name were provided. A follow up call was made with the clinic associated with pt's home treatment in order to gather additional details about the events surrounding the pt's death. It was reported the pt transferred their dialysis treatment elsewhere. This clinic reported two known locations the pt received treatment. Follow ups with those two locations were unable to provide additional info regarding the pt or the pt's death. An internet search was conducted to locate pt's date of birth and date of death. The pt's date of death was reported as (b)(6) 2013. No further info could be obtained in regards to the sequence of events leading up to and including the pt's death. No reported allegations were made against the machine.
Patient Sequence No: 1, Text Type: D, B5
[38089726]
No devices were returned to the mfr for physical evaluation and field service was not requested; therefore, the failure mode cannot be confirmed. Serial number was not provided. All products are released to spec.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2015-01720 |
| MDR Report Key | 5313334 |
| Report Source | OTHER |
| Date Received | 2015-12-16 |
| Date of Report | 2015-12-16 |
| Date of Event | 2013-10-25 |
| Date Mfgr Received | 2015-12-04 |
| Date Added to Maude | 2015-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TANYA TAFT, RN CNOR |
| Manufacturer Street | 920 WINTER STREET |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 8006621237 |
| Manufacturer G1 | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Street | 4040 NELSON AVENUE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS 2008K@HOME |
| Product Code | ONW |
| Date Received | 2015-12-16 |
| Model Number | K@HOME |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | CONCORD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-12-16 |