MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-08-01 for 2008K@HOME MACHINE manufactured by Concord Manufacturing.
[81516440]
Plant investigation: no parts were returned to the manufacturer for physical evaluation. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the serial number of the 2008k@home hemodialysis (hd) machine in question was not known. 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. Clinical investigation: any possibility of causality between the event of collapsing at the end of a hemodialysis (hd) treatment and the 2008k@home hd machine cannot be assessed based on the lack of information provided. Should additional information become available the possibility of causality will be re-evaluated.
Patient Sequence No: 1, Text Type: N, H10
[81516441]
A user post on the message forum of a dialysis website reported an event experienced by the user, who is also the patient. The post stated that the patient alleges at the end of hemodialysis (hd) treatment on a fresenius 2008k@home hd machine, the patient collapsed. The patient discontinued use of the machine at some point after this and changed the machine to a different manufacturer due to this event. Based on the information, it is estimated the alleged event occurred approximately 3. 5 years ago. No further information has been made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2017-00663 |
| MDR Report Key | 6757668 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-08-01 |
| Date of Report | 2017-08-01 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2017-07-11 |
| Date Added to Maude | 2017-08-01 |
| 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 | 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 | 2017-08-01 |
| 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. Other | 2017-08-01 |