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 2020-03-04 for DRY ACID 132 GALLON UNIT, ASSY TO SHIP 160147 RTL160147 manufactured by Concord Manufacturing.
[181908518]
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
[181908519]
A user facility biomedical technician (biomed) reported sparking coming from the fill valve on a dry acid mixer. Upon follow up, it was reported that a burning smell and a little bit of smoke also came from the machine. No further signs of burn damage were noted. The biomed replaced the fill valve and this did not fix the machine. The biomed then replaced the board in the display screen and the cable that connects to the fill valve, and that resolved the reported issue. After fixing the filling issue, an (unspecified) issue with the mixer motor surfaced. To resolve that issue, the biomed replaced the mixer motor. The biomed confirmed the machine was plugged into an appropriate outlet. At the time of follow up, the dry acid mixer was reported to be fully operational. There have been no further issues with the machine. The parts that were replaced have been discarded. There was no sample available to be returned for manufacturer evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00426 |
| MDR Report Key | 9784402 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2016-12-09 |
| Date Added to Maude | 2020-03-04 |
| 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 |
| 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 | DRY ACID 132 GALLON UNIT, ASSY TO SHIP |
| Generic Name | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
| Product Code | KPO |
| Date Received | 2020-03-04 |
| Model Number | 160147 |
| Catalog Number | RTL160147 |
| 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 | 2020-03-04 |