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 2020-03-20 for 2008T HEMODIALYSIS SYS., WITH CDX 190713 manufactured by Concord Manufacturing.
[184366503]
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
[184366504]
A biomedical technician (biomed) reported that the hemodialysis (hd) machine was powered on and a popping sound and burning smell from the power supply occurred. The machine was powered off and discolored wires from the power switch to power control board were found. Upon follow-up, the biomed it was confirmed that the wires were burned and discolored. There was no observation of any smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burned wires. The biomed stated that the machine has 8,289 hours and that the power supply board is the original fresenius part on the machine. The biomed stated that the power supply board and rocker switch were replaced, which resolved the machine issue. It was reported that the machine will undergo additional testing before being returned back into service. The biomed confirmed that a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. The biomed stated that the power supply board and rocker switch are available for return to the manufacturer for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00523 |
| MDR Report Key | 9862786 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-20 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2015-04-29 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| 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 | 2020-03-20 |