MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-20 for FRESENIUS K@HOME HEMO W/PRIME BAG 03-2962-3 manufactured by Fresenius Medical Care North America.
[32262907]
The blood lines were not returned to the manufacturer for physical evaluation and the plant investigation is on-going. A supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[32262908]
A user facility reported a patient experienced clotting within the blood lines of their home hemodialysis machine and conductivity alarms. This occurred approximately 2 hours into treatment. Due to the multitude of the clot, the patient was unable to have their blood returned from the lines. The patient was reported to have heparin induced thrombocytopenia, and therefore, could not increase the dosage of heparin in order to combat the clotting. Blood platelet level of 89,000 microl was reported. Patient's blood analysis concluded that the patient's kv/t was running around 1. 4, therefore, the patient wasn't getting adequate dialysis. The patient's dialysis time was increased from 3:15/4 times a week to 3:30/4 times a week, but this did not improve the patient's kv/t. The patient did not exhibit any adverse symptoms or require medical intervention at any time. The patient had requested his previous home dialysis machine, and was provided with such. The clotting has not re-occurred to date. The reported machine was removed from service and was calibrated for conductivity. The home user facility has not put the machine back into service.
Patient Sequence No: 1, Text Type: D, B5
[37067587]
The device was not returned to the manufacturer for physical evaluation and field service was not requested; therefore, the failure mode cannot be confirmed. An investigation of the device manufacturing and labeling could not be completed as the lot number was not available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030665-2015-00549 |
| MDR Report Key | 5250017 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-20 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-09-12 |
| Date Mfgr Received | 2015-11-02 |
| Date Added to Maude | 2015-11-25 |
| 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 | TANYA TAFT, RN, CNOR |
| Manufacturer Street | 920 WINTER STREET |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 8006621237 |
| Manufacturer G1 | REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN 1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA, TAMAULIPAS, CP 88780 |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS K@HOME HEMO W/PRIME BAG |
| Product Code | ONW |
| Date Received | 2015-11-20 |
| Catalog Number | 03-2962-3 |
| Operator | HEALTH PROFESSIONAL |
| 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 | REYNOSA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-20 |