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 |