MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-29 for 2008K@HOME HEMODIALYSIS SYSTEM 190828 manufactured by Concord Manufacturing.
[98549612]
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). The biomedical technician (biomed) reportedly replaced the blood pump and the air detector, and reseated and the card cage boards to resolve the issue. Following parts replacement, the unit was returned to service at the patient? S home without a recurrence of the event as reported. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances or any associated rework during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Patient Sequence No: 1, Text Type: N, H10
[98549613]
A biomedical engineer (biomed) reported that a home hemodialysis (hd) patient was having issues returning their blood at the end of hd treatment while using a fresenius 2008k@home hd machine. The patient reportedly was unable to return his blood at the end of treatment when the message? Tx disconnect?? Appeared on the machine for re-infusion. The estimated blood loss was 100ml. There was no patient injury or adverse reaction reported. No medical intervention was required. Following the event, the biomed evaluated the machine at the patient? S home. The biomed replaced the blood pump and the air detector, and reseated and the card cage boards. The patient continues to use the machine and did not miss any treatments or have any further issues. No parts are reported to be available to be returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2018-00283 |
| MDR Report Key | 7224739 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-29 |
| Date of Report | 2018-01-29 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-10 |
| Device Manufacturer Date | 2013-07-15 |
| Date Added to Maude | 2018-01-29 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 HEMODIALYSIS SYSTEM |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2018-01-29 |
| Model Number | 2008K@HOME |
| Catalog Number | 190828 |
| 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 | 2018-01-29 |