MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-03 for 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP 190395 manufactured by Fresenius Medical Care North America.
[52003874]
(b)(4). No parts were returned to the manufacturer for physical evaluation. The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[52003875]
A home hemodialysis (hhd) patient reported that the 2008k at home machine generated a "dial valve 1" alarm approximately 5. 5 hours into the nocturnal hd treatment. The alarm occurred around 3:30 am during the patient's (b)(6) 2016 hhd therapy. The patient was not able to clear the alarm, so the unit was powered down, and then back up, but it failed to power on in a "timely manner. " this resulted in the loss of blood within the entire extracorporeal circuit. The patient's estimated blood loss (ebl) was noted as being approximately 250cc. There were no patient adverse effects or medical intervention required as a result of this event. Following the event, a fresenius regional equipment specialist (res) performed an on-site evaluation of the unit. The res replaced the actuator/test board and microswitch to resolve the issue. Functional testing performed by the res confirmed the unit was operating properly. The unit was repaired and the res noted that it was ready to be returned to service, however, the current service status of the machine is not known. Although requested, no further information has been received from the user facility.
Patient Sequence No: 1, Text Type: D, B5
[58087563]
No parts were returned to the manufacturer for physical evaluation. The 2008k at home hemodialysis machine was evaluated at the facility by a fresenius regional service technologist (rst). Machine functional checks were performed. The machine? S total conductivity, temperature, and electrical safety were verified with an external meter. The fresenius technician replaced the actuator/test board and microswitch to resolve the issue. Functional testing performed by the rst confirmed the unit was operating properly. The unit was repaired and the rst noted that it was ready to be returned to service, however, the current service status of the machine is not known. Although requested, no further information has been received from the user facility. 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 investigation into the cause of the reported problem was able to confirm the failure mode, dial valve failure. Although a regional service technologist performed an on-site repair of the unit, no parts were returned to the manufacturer for physical examination. Therefore, a definitive conclusion regarding the complaint incident cannot be reached.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2016-00817 |
| MDR Report Key | 5843392 |
| Date Received | 2016-08-03 |
| Date of Report | 2016-10-20 |
| Date of Event | 2016-07-12 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2012-12-04 |
| Date Added to Maude | 2016-08-03 |
| 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 | PATIENT |
| 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 | 2016-08-03 |
| Catalog Number | 190395 |
| ID Number | 00840861100958 |
| 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 | 2016-08-03 |