MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-12-30 for K MACHINE manufactured by Fresenius Medical Care North America.
[35210834]
A supplemental medwatch report will be submitted upon completion of the investigation and/or receipt and review of medical patient's medical records.
Patient Sequence No: 1, Text Type: N, H10
[35210835]
A letter of correspondence was sent to a home hemodialysis patient. In return, a note from the patient's spouse was received indicating she had expired on (b)(6) 2014. The spouse was contacted to follow up regarding the patient's death. No further information or cause of death was provided. As of the present time, there is no additional information regarding the type of hemodialysis machine that was used prior to the patient's death. A medical records have been requested but not yet received.
Patient Sequence No: 1, Text Type: D, B5
[37125347]
Retract: during investigation it was discovered that the event reported in mdr 2937457-2015-01767 was also reported in mdr 1225714-2016-00001. There was only a single device involved in the event of death. All further information and evaluation will be reported as a follow-up to mdr 1225714-2016-00001.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2015-01767 |
| MDR Report Key | 5346646 |
| Report Source | OTHER |
| Date Received | 2015-12-30 |
| Date of Report | 2015-12-30 |
| Date of Event | 2014-12-16 |
| Date Mfgr Received | 2015-12-09 |
| Date Added to Maude | 2016-01-06 |
| 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 | CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA |
| 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 | K MACHINE |
| Product Code | ONW |
| Date Received | 2015-12-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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; 2. Hospitalization | 2015-12-30 |