MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-11 for 2008K@HOME MACHINE UNKNOWN-2008K@HOME MACHINE manufactured by Concord Manufacturing.
[108003639]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[108003640]
This is a report of a hemodialysis patient who expired. A patient letter envelope regarding a software upgrade letter was received indicating that the patient passed away. No further information is available at this time. Should additional information become available, the file will be reassessed and updated accordingly.
Patient Sequence No: 1, Text Type: D, B5
[109539758]
Plant investigation: the actual device was not returned to the manufacturer for physical evaluation. Furthermore, an investigation of the device manufacturing records was not able to be conducted by the manufacturer as the product serial number of the device was unknown, therefore an investigation of the device manufacturing records was unable to be conducted by the manufacturer. However; a device is not released if it does not meet requirements or is nonconforming. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[109539759]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2018-01318 |
| MDR Report Key | 7507145 |
| Report Source | CONSUMER |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-05-16 |
| Date Added to Maude | 2018-05-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | CONCORD MANUFACTURING |
| 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 | 2008K@HOME MACHINE |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2018-05-11 |
| Catalog Number | UNKNOWN-2008K@HOME MACHINE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONCORD MANUFACTURING |
| Manufacturer Address | 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-05-11 |