MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-23 for 2008T HEMODIALYSIS SYS., WITH CDX 190713 manufactured by Concord Manufacturing.
[184484933]
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
[184484974]
A user facility biomedical technician (biomed) reported that the hemodialysis (hd) machine had a low temp in heat disinfect. It was reported the power control board was the cause and a burn mark was noticed on the board. A new board was installed which also burnt out. A burning smell was reported but there was no fire or smoke. The biomed was advised to swap the power supply. Additional information was requested but to date, has not been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00527 |
| MDR Report Key | 9866133 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-23 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2014-11-17 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | CONCORD MANUFACTURING |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 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 | 2008T HEMODIALYSIS SYS., WITH CDX |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-23 |
| Model Number | 190713 |
| Catalog Number | 190713 |
| Operator | HEALTH PROFESSIONAL |
| 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 | DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |