MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2016-01-14 for FRESENIUS 2008K@HOME manufactured by Fresenius Medical Care North America.
[35990542]
(b)(4). The device was not returned to the manufacturer for physical evaluation and field service was not requested; therefore, the failure mode cannot be confirmed. All device history records are reviewed and released according to "dhr review checklist & release procedure. " if a device does not meet requirements, or is non-conforming, it will not be released.
Patient Sequence No: 1, Text Type: N, H10
[35990543]
An undelivered mail liquid bicarb notification was received indicating this home hemodialysis patient was deceased. No further details were provided. A follow up call was made to the clinic associated with patient's home treatment in order to gather additional details about the events surrounding the patient's death. It was reported the patient was not exposed to the recalled liquid bicarb and had transferred their dialysis treatment to an unknown dialysis clinic. An internet search for the patient's obituary revealed the patient's (b)(6) and date of death as (b)(6) 2014. No further information could be obtained in regards to the sequence of events leading up to and including the patient's death. No reported allegations were made against the machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2016-00045 |
| MDR Report Key | 5367764 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2016-01-14 |
| Date of Report | 2016-01-14 |
| Date of Event | 2014-08-20 |
| Date Mfgr Received | 2015-12-21 |
| Date Added to Maude | 2016-01-14 |
| 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 | CNOR TANYA TAFT |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | CONCORD PLANT |
| Manufacturer Street | 4040 NELSON AVE. |
| 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 |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE |
| Product Code | ONW |
| Date Received | 2016-01-14 |
| Catalog Number | K@HOME |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | 4040 NELSON AVE. CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-01-14 |