MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-16 for 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG 190904 manufactured by Concord Manufacturing.
[117314289]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.? Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k @home hemodialysis system w/bibag, and the adverse event of death. Based on the information available, the etiology of the patient? S expiration is unknown; therefore causality cannot be determined. However, it is known that end stage renal disease (esrd) patients receiving renal replacement therapy (rrt) have a significantly higher mortality rating, when compared to the general population. Furthermore, there is no indication and/or documentation the 2008k @home hemodialysis system w/bibag caused or contributed to the adverse event. Additionally, there is no allegation of a malfunction or of the machine failing to perform as expected in relation to this event as evidenced by the completed regional equipment specialist (res) service records.
Patient Sequence No: 1, Text Type: N, H10
[117314330]
A user facility reported a patient who expired during their (b)(6) 2018 dialysis treatment while using a fresenius 2008k@home hemodialysis machine. There were no machine alarms reported. Due diligence attempts were exhausted, but no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[118463393]
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
[118463394]
Patient Sequence No: 1, Text Type: D, B5
[118786785]
Updated plant investigation: no parts were returned to the manufacturer for physical evaluation. An on-site evaluation was performed by a fresenius regional equipment specialist (res), who determined that the machine passed the ultrafiltration function test and all other functional checks. The res noted that the machine displayed a high flow error once for two seconds, which did not reappear. The customer reportedly would perform a repair on the flow recirculation error at a later date. 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.
Patient Sequence No: 1, Text Type: N, H10
[118786786]
Patient Sequence No: 1, Text Type: D, B5
[118787186]
Updated plant investigation: no parts were returned to the manufacturer for physical evaluation. An on-site evaluation was performed by a fresenius regional equipment specialist (res), who determined that the machine passed the ultrafiltration function test and all other functional checks. The res noted that the machine displayed a high flow error once for two seconds, which did not reappear. The customer reportedly would perform a repair on the flow recirculation error at a later date. 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.
Patient Sequence No: 1, Text Type: N, H10
[118787187]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2018-02371 |
| MDR Report Key | 7789626 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-16 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2014-12-30 |
| Date Added to Maude | 2018-08-16 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2018-08-16 |
| Catalog Number | 190904 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2018-08-16 |