MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-01-06 for FRESENIUS 2008K@HOME manufactured by Fresenius Medical Care North America.
[35613050]
No parts were 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
[35613051]
A correspondence letter was received from the pt's daughter which indicated the pt was deceased. A follow up call was made with the clinic associated with pt's home treatment in order to gather additional details about the event surrounding the pt's death. Per the pt's registered nurse (rn) , the pt went to the hospital (reason unk), then went to rehab. Following rehab the pt returned to the hospital where she had a heart attack and passed away. According to the rn, the pt did not dialyze with the clinic during the time period between her initial hospitalization and her death. An internet search was conducted to locate pt's date of birth and it was determined that she was (b)(6) at the time of her passing. No further info could be obtained in regards to the sequence of events leading up to the pt's death. No reported allegations were made against the machine. Medical records have been requested.
Patient Sequence No: 1, Text Type: D, B5
[38307117]
The device was not returned to the mfr for physical evaluation, and the machine serial number was not able to be obtained to date. Multiple attempts were made to obtain add'l info, however, they were unsuccessful. An investigation of the device mfg records was not able to be conducted by the mfr as the serial number of the 2008k@home hemodialysis machine in question was not provided. However, all device history records (dhr) are reviewed and released according to the "dhr review checklist and release procedure". P/n 500658; a device is not released if it does not meet requirements or is nonconforming. No medical records were made available, therefore, there is no way to confirm a causal relationship between the 2008k@home hemodialysis machine and the patient's death.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2016-00010 |
| MDR Report Key | 5357021 |
| Report Source | OTHER |
| Date Received | 2016-01-06 |
| Date of Report | 2016-01-06 |
| Date of Event | 2015-09-02 |
| Date Mfgr Received | 2015-12-10 |
| Date Added to Maude | 2016-01-11 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS 2008K@HOME |
| Product Code | ONW |
| Date Received | 2016-01-06 |
| Operator | LAY USER/PATIENT |
| 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 | 2016-01-06 |