MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-14 for 2008K@HOME MACHINE UNKNOWN-2008K@HOME MACHINE manufactured by Concord Manufacturing.
[108225279]
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
[108225280]
A medical professional (md) reported that when the reverse osmosis (r. O) machine for one of their hemodialysis (hd) patient needed maintenance and was replaced, the patient immediately began having a bad taste in his mouth, headache, became hypertensive, and reported having an edema during treatment. Upon follow up, the md stated that some symptoms (unspecified) went away after the patient stopped using saline flushes during treatment; however the patient symptoms of headache and bad taste still persisted. Per md the hose that connects the r. O machine to the 2008k@ home machine was replaced again and the symptoms returned. The patient is now performing in-center hemodialysis (hd) with no further issues. Per md the cause of patient symptoms is unknown. Additional information regarding patient treatment records, patient demographics, machine information, r. O information was requested; however, not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2018-01337 |
| MDR Report Key | 7512679 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-25 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2018-05-16 |
| Date Added to Maude | 2018-05-14 |
| 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 MACHINE |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2018-05-14 |
| 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 | 2018-05-14 |