MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-04 for FRESENIUS K@HOME HEMO W/ PRIME BAG 03-2962-3 manufactured by Fresenius Medical Care North America.
[44893200]
(b)(4). The complaint device was not returned for analysis; however, a companion sample from the same lot was made available to the manufacturer for physical evaluation and a functional analysis. A visual examination was performed on the tubing set and drainage bag of the companion sample; no defects were identified. The companion sample was then tested using a 2008t hemodialysis machine for simulated use. The bloodline was able to be primed with no visible issues. During the simulated use test, fluid flowed through the lines without issue. No alarms were generated and there were no observations of a frothy fluid or any other foreign matter in the venous chamber during the simulated use test. The device worked as intended with no noted abnormalities and no defects identified. A records review was performed on the reported lot. 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 batch record review confirmed the labeling, material, and process controls were within specification. The investigation into the cause of the reported problem was not able to confirm the failure mode. The reported defect of frothy fluid identified in venous chamber was not duplicated. The evaluation of the companion sample confirmed that the devices functioned fully as designed and met specification.
Patient Sequence No: 1, Text Type: N, H10
[44893201]
A user facility home hemodialysis nurse reported that approximately one hour into a patient's home hemodialysis (hd) treatment, a venous pressure alarm occurred. Reportedly, a clear frothy fluid was observed in the venous chamber by the patient's spouse. The treatment was terminated without rinsing back the blood within the bloodline circuit. The patient's estimated blood loss (ebl) was approximately 200cc. No adverse effects were experienced by the patient as a result of this event and no medical intervention was required. The complaint device is not available for evaluation, however, the user facility provided a companion sample to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2016-00210 |
| MDR Report Key | 5630379 |
| Date Received | 2016-05-04 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-02-16 |
| Date Mfgr Received | 2016-02-17 |
| Device Manufacturer Date | 2015-07-10 |
| Date Added to Maude | 2016-05-04 |
| 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 | CNOR TANYA TAFT |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA, TAMAULIPAS CP 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FRESENIUS K@HOME HEMO W/ PRIME BAG |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE |
| Product Code | ONW |
| Date Received | 2016-05-04 |
| Returned To Mfg | 2016-04-06 |
| Catalog Number | 03-2962-3 |
| Lot Number | 15JR01234 |
| ID Number | 00840861100330 |
| Device Expiration Date | 2018-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA, TAMAULIPAS CP 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-04 |