MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-11-17 for 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG 190904 manufactured by Concord Manufacturing.
[119843083]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.?
Patient Sequence No: 1, Text Type: N, H10
[119843084]
A property manager reported finding a fresenius 2008k@home machine when cleaning out a residence, and reported that the patient was deceased. Due diligence attempts were exhausted, but no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[120298340]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.? Clinical investigation: at this time, there have been no reported fresenius 2008k@home product deficiencies or malfunctions associated with the death event. At this time, there is no allegation or documentation that indicates the 2008k@home dialysis machine caused or contributed to the patient? S death.
Patient Sequence No: 1, Text Type: N, H10
[120298341]
Patient Sequence No: 1, Text Type: D, B5
[122848853]
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). 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 identified during the manufacturing process which could be related to 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 not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Patient Sequence No: 1, Text Type: N, H10
[122848854]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2018-02672 |
| MDR Report Key | 7865056 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-10-19 |
| Date Mfgr Received | 2018-09-20 |
| Device Manufacturer Date | 2016-10-31 |
| Date Added to Maude | 2018-09-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 HEMODIALYSIS SYSTEM W/ BIBAG |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2017-11-17 |
| Catalog Number | 190904 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Death | 2017-11-17 |