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 2017-08-07 for 2008K@HOME HEMODIALYSIS SYSTEM 190828 manufactured by Concord Manufacturing.
[81962415]
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[81962416]
A home hemodialysis (hd) therapies nurse reported that a home hd patient is switching to the nxstage machine due to multiple issues observed while using the fresenius 2008k@home machine for positive culture test results, resulting in the patient having back-up treatment at a dialysis clinic. The nurse stated that the clinics are full and sometimes the patient would have to drive over an hour away to get treatment. The patient reportedly lives in a remote area and works full time, causing inconvenience. In addition, the patient? S medical doctor (md) has instructed that the patient complete hd treatment either four (4) days per week for four (4) hours, or three (3) days a week for five (5) hours fifteen (15) minutes on the 2008k@home machine. The md allows for the patient to run extra treatments as needed, as the patient has severe lymphedema, current weight of approximately (b)(6), and is short of breath the majority of the time and may need additional fluid removal. The md would prefer that the patient complete hd treatment every day, however, the patient denies to comply with these instructions. In addition, the patient has difficulty sitting long enough to complete a 5 hours 15 minutes hd session due to back issues. The nurse stated that the nxstage machine would allow for the patient to run hd treatment six (6) days per week for 3 hours. This submission is being filed for positive culture samples that were taken on (b)(6) 2017 where the colony count and endotoxin results were high. No patient adverse effects or injuries were experienced and no medical intervention was required. The nurse redrew samples on (b)(6) 2017 and the endotoxin results came back normal, but the colony count was above specification limits. A biomedical engineer (biomed) performed service on the machine. The biomed replaced the diasafe filter and bleached the machine. Samples were drew (b)(6) 2017 and the results were within specification limits. No parts are available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2017-00691 |
| MDR Report Key | 6771556 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-07 |
| Date of Report | 2017-08-30 |
| Date of Event | 2017-07-05 |
| Date Mfgr Received | 2017-08-24 |
| Device Manufacturer Date | 2014-06-09 |
| Date Added to Maude | 2017-08-07 |
| 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 | 2017-08-07 |
| 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 | 2017-08-07 |