MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-18 for FRESENIUS 2008K@HOME HEMODIALYSIS SYSTEM WITH BIBAG 190904 manufactured by Fresenius Medical Care North America.
[38641539]
(b)(4). Findings to date determined the patient's actuator board required replacing. The biomedical technician has received the new actuator board and is currently running tests on the device. A supplemental report will be filed upon completion of the plant investigation.
Patient Sequence No: 1, Text Type: N, H10
[38641540]
A k@home hemodialysis patient's biomedical technician reported the device was removing too much fluid during treatment. The patient reported his treatment on (b)(6) 2016 resulted in ultra-filtration (uf) greater than 1,000 ml. The patient and his wife turned off the uf and the patient was given 600ml of saline to replace the lost fluids. The patient reported he was fine and had no further details to report, such as machine settings and error messages. The patient required no medical intervention. Follow-up with the patient's dialysis nurse confirmed the k@home machine pulled more than programmed amount of fluid and patient compensated by lowering uf goal. For this event, the uf goal was set at 200ml and machine pulled of greater than 1,000ml of fluid. The patient has since experienced weakness and headaches but has not required medical intervention. The patient is currently undergoing inpatient hemodialysis.
Patient Sequence No: 1, Text Type: D, B5
[40145364]
The device was not returned to the manufacturer for physical evaluation, therefore, the failure mode cannot be confirmed. However, 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 deviations or non-conformances during the manufacturing process. In addition, the dhr record review confirmed the labeling, material, and process controls were within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2016-00180 |
| MDR Report Key | 5443994 |
| Date Received | 2016-02-18 |
| Date of Report | 2016-03-11 |
| Date of Event | 2016-01-22 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2015-02-23 |
| Date Added to Maude | 2016-02-18 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CNOR TANYA TAFT |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | CONCORD PLANT |
| Manufacturer Street | 4040 NELSON AVE. |
| 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 | FRESENIUS 2008K@HOME HEMODIALYSIS SYSTEM WITH BIBAG |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE |
| Product Code | ONW |
| Date Received | 2016-02-18 |
| Catalog Number | 190904 |
| ID Number | 00840861100965 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-02-18 |