MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-01-06 for FRESENIUS 2008K@HOME 190395 manufactured by Fresenius Medical Care North America.
[35988324]
A supplemental report will be filed upon completion of the plant investigation.
Patient Sequence No: 1, Text Type: N, H10
[35988325]
A home dialysis pt called the mfr to report she was having problems with the venous pressure lines. The pt reported she had started treatment when the venous pressure read zero. She set up a new venous line and the venous pressure continued to read zero. She set up new needle and noticed that the blood in the venous side was back. The pt returned her blood on the arterial side and reports a blood loss of less than 200cc from venous side. Pt discarded tubing. The pt did not continue her hemodialysis until the next day. On (b)(6) 2015, she reports the treatment on (b)(6) 2015 was without event and ran as expected.
Patient Sequence No: 1, Text Type: D, B5
[38106666]
Device review: the pt did not request service from the mfr's regional equipment specialist. After several requests, the pt did not provide the serial number of the machine. As a result, a device history record review could not be performed. All device history records (dhr) are reviewed and released according to "dhr review checklist and release procedure". A device is not released if it does not meet requirements or is non-conforming. The pt's biomedical technician reported that there were no problems with the machine. The pt's home therapies rn reported that the pt had no further problems with her treatments following the event.
Patient Sequence No: 1, Text Type: N, H10
[39109168]
Device review: the complaint device is unavailable for investigation. A device history record review was performed which included labeling reconciliation, material/component traceability, non-conformance's and/or any associated rework potentially related to the reported complaint, scrap rates, environmental controls, results on in-process and final qc testing, process controls. The review found the k@home device was manufactured to specifications with no unexpected variances or adjustments. The patient's biomedical technician reported there was no problem with the patient's machine. The patient's rn has reported that treatments have run without any problems since this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2016-00011 |
| MDR Report Key | 5357114 |
| Report Source | CONSUMER |
| Date Received | 2016-01-06 |
| Date of Report | 2016-01-06 |
| Date of Event | 2015-12-18 |
| Date Mfgr Received | 2015-12-18 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2016-01-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TANYA TAFT, RN, CNOR |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999751 |
| Manufacturer G1 | FRESENIUS MEDICAL CARE NORTH AMERICA |
| 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 | 0 |
| Brand Name | FRESENIUS 2008K@HOME |
| Product Code | ONW |
| Date Received | 2016-01-06 |
| Catalog Number | 190395 |
| 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 | CONCORD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-06 |