MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-30 for DISSOLUTION UNIT-TESTED G047-80101 manufactured by Concord Manufacturing.
[143618179]
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
[143618180]
A biomedical technician (biomed) at a user facility reported that a fresenius dissolution unit had a visibly burned fill valve. The burned component was found while servicing the machine for a report of smoke that was observed coming from the machine during use. 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 burned fill valve was the original fresenius part on the machine. The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned fill valve. The biomed replaced the fill valve, which resolved the issue. The unit was returned to service at the user facility without issue and without reoccurrence of the event. The fill valve was discarded by the biomed and is not available to be returned to the manufacturer for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2019-01269 |
| MDR Report Key | 8566845 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-30 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-04-19 |
| Date Mfgr Received | 2019-05-14 |
| Device Manufacturer Date | 2008-07-02 |
| Date Added to Maude | 2019-04-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 | 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 | DISSOLUTION UNIT-TESTED |
| Generic Name | BLENDER/MIXER |
| Product Code | JRO |
| Date Received | 2019-04-30 |
| Catalog Number | G047-80101 |
| 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 | 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-30 |