MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for DISSOLUTION UNIT-TESTED G047-80101 manufactured by Concord Manufacturing.
[130624535]
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
[130624536]
A user facility biomed reported a fresenius dissolution unit mixer with smoke and visible flame coming from the recirculation pump motor area. The facility smoke detectors sounded, and a clinic employee used a fire extinguisher to put out the file. The clinic was evacuated and the local fire department was on site. The biomed confirmed that 19 patients were undergoing treatment when the issue occurred, and confirmed that per the clinic protocol, each of the patient? S had their blood returned before leaving the clinic. The biomed confirmed that no patient had any blood loss, and there was no patient harm, injury, adverse event, or medical intervention as a result of the fire. The biomed confirmed that upon further inspection of the mixer, the apparent cause of the fire seemed to be a solenoid valve for the recirculation pump. The biomed confirmed that the machine had not been repaired, and confirmed a replacement mixer had been ordered to replace it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2018-03676 |
| MDR Report Key | 8168717 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2008-10-14 |
| Date Added to Maude | 2018-12-17 |
| 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 | 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 | 0 |
| Brand Name | DISSOLUTION UNIT-TESTED |
| Generic Name | BLENDER/MIXER |
| Product Code | JRO |
| Date Received | 2018-12-17 |
| 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 | 2018-12-17 |