MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-07 for K@HOME manufactured by Fresenius Medical Care North America.
[47313163]
(b)(4). Investigations findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and not during dialysis mode. The user visually observed the saline bag refilling with dialysate during circulation. There have been no adverse events associated with the reported issue. The report is being investigated by the manufacturer via a capa. The investigation is pending a supplemental mdr will be filed at the completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[47313164]
A user facility reported a saline bag back filled during recirculation mode. A patient was not connected to the machine at the time of the incident. There were no parts replaced on the device by the technician and the machine was returned to service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2016-00589 |
| MDR Report Key | 5703278 |
| Date Received | 2016-06-07 |
| Date of Report | 2016-06-07 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-06-01 |
| Device Manufacturer Date | 2007-11-22 |
| Date Added to Maude | 2016-06-07 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TANYA TAFT |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | WALNUT CREEK |
| Manufacturer Street | 4040 NELSON AVE. |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0629-2014 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | K@HOME |
| Generic Name | ONW |
| Product Code | ONW |
| Date Received | 2016-06-07 |
| Catalog Number | K@HOME |
| Lot Number | 7K0S107924 |
| Operator | HOME HEALTH AIDE |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | 4040 NELSON AVE. CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-07 |