MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-05-11 for 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP 190395 manufactured by Concord Manufacturing.
[75012241]
No parts were returned to the manufacturer under failure analysis for physical evaluation. The 2008k@home hemodialysis (hd) machine was evaluated on-site by a fresenius medical care (b)(4) regional service representative (rsr). The rsr replaced the actuator board with a newer version, and then performed a simulated treatment. Functional testing performed by the rsr confirmed that the system was operating properly. The patient was able to continue their regularly scheduled home hemodialysis (hhd) treatments using this machine without a recurrence of the reported event. 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 non-conformances or any associated rework during the manufacturing process which could be associated with the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was able to confirm the failure mode. The fmcc rsr replaced the actuator board with a newer version to resolve the issue. Therefore, the complaint has been deemed confirmed.
Patient Sequence No: 1, Text Type: N, H10
[75012242]
A home hemodialysis (hhd) patient reported to a fresenius medical care (b)(4) regional service representative (rsr) that the 2008k@home hd machine generated a "dial valve error 1 alarm" approximately one hour after the hd treatment was initiated. Following the alarm, the patient disconnected from the machine without rinsing back the blood within the extracorporeal circuit as per procedure. The patient's estimated blood loss (ebl) was noted as being approximately 100 milliliters (ml). No visible issues or defects were identified with the bloodline or dialyzer products. No patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient ended the hhd treatment to allow for the on-site evaluation of the system by a rsr. Following the event, the rsr performed an on-site evaluation of the unit. The rsr checked valves 24, 25, and 26 and checked the connection to the ground; all checks were satisfactory. The rsr replaced the actuator board with a newer version, and then performed a simulated treatment. Functional testing performed by the rsr confirmed that the system was operating properly. No parts were returned to the manufacturer for physical examination. The patient was able to continue their regularly scheduled hd treatments using this machine. No scheduled treatments were missed following this event, and no additional, unscheduled hd therapy was performed as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2017-00353 |
| MDR Report Key | 6560251 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-05-11 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-04-12 |
| Date Mfgr Received | 2017-04-12 |
| Device Manufacturer Date | 2013-05-22 |
| Date Added to Maude | 2017-05-11 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | CONCORD MANUFACTURING |
| Manufacturer Street | 4040 NELSON AVENUE |
| 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 | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2017-05-11 |
| Model Number | 2008K@HOME |
| Catalog Number | 190395 |
| ID Number | 00840861100958 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONCORD MANUFACTURING |
| Manufacturer Address | 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-11 |