MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-08-26 for 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP 190395 manufactured by Fresenius Medical Care North America.
[53135768]
(b)(4). The device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis. The hemodialysis (hd) coordinator indicated that the incident was related to blood pressure management and was unrelated to any fresenius products or equipment. The unit has been returned to service at the user facility without a recurrence of the event as reported. 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 which could be associated with the reported event. In addition, the device history record (dhr) review confirmed the labeling, material, and process controls were within specification. The reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation. As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. No medical records were made available; therefore, there is no way to confirm a causal relationship between the 2008k@home hemodialysis (hd) machine and the patient? S hospitalization.
Patient Sequence No: 1, Text Type: N, H10
[53135769]
A home hemodialysis (hd) coordinator reported a patient incident involving a home hd patient to a fresenius (b)(4) regional service representative. The patient's treatment was terminated after 2. 5 hours into an 8 hour session and the patient was taken to a hospital emergency room (er). The patient returned home approximately 9 hours later the same day. No blood loss was reported. The patient has been on hd for 5 years. No machine malfunction was alleged, identified, or observed during the hd treatment. Furthermore, the medical professionals confirm that the reason for the patient's hospitalization is not related to the fresenius home hd equipment or disposable products. The hd coordinator indicated that the incident was related to blood pressure management and was unrelated to any fresenius products or equipment. The patient has had successful treatments using fresenius products after the incident. No further information has been made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2016-00922 |
| MDR Report Key | 5908416 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-26 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-02 |
| Device Manufacturer Date | 2011-06-21 |
| Date Added to Maude | 2016-08-26 |
| 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 | MR. THOMAS JOHNSON |
| 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 | 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE |
| Product Code | ONW |
| Date Received | 2016-08-26 |
| Catalog Number | 190395 |
| ID Number | 00840861100958 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Hospitalization | 2016-08-26 |