MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-06-06 for FRESENIUS 2008K@HOME manufactured by Fresenius Medical Care North America.
[46636111]
(b)(4). Plant investigation is in process. A supplemental mdr will be submitted at the completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[46636112]
A home hemodialysis nurse reported that one of her patients expired prior to undergoing treatment, while preparing the equipment for use. The patient was found unresponsive by their spouse who then contacted emergency medical services (ems) for assistance. The patient was transferred to the hospital via ambulance, but expired prior to their arrival. The patient's last successful hemodialysis treatment was performed on (b)(6) 2016. Follow-up information was provided by the home hd nurse who revealed that the patient's death was unrelated to the use of fmcc equipment or disposables. No further information has been made available.
Patient Sequence No: 1, Text Type: D, B5
[58722648]
The event reported against the 2008k at home hemodialysis (hd) machine in mdr id #2937457-2016-00584 was submitted in error. The patient was confirmed to have been in the process of setting up the hemodialysis (hd) machine for use, when they became unresponsive. The user had not been receiving hd treatment at the time the event occurred. Per the registered nurse, "the death was unrelated to use of fmcc equipment or disposables. " therefore, this is no longer considered an mdr-reportable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2016-00584 |
| MDR Report Key | 5701618 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-06 |
| Date of Report | 2016-10-28 |
| Date of Event | 2016-05-09 |
| Date Mfgr Received | 2016-10-14 |
| Date Added to Maude | 2016-06-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE |
| Product Code | ONW |
| Date Received | 2016-06-06 |
| 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 | 1. Death | 2016-06-06 |