MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for LIBERTY SELECT CYCLER ASSY(NON-VALUATED) 180343 RTLR180343 manufactured by Concord Manufacturing.
[185525584]
Plant investigation: the actual device was returned to the manufacturer for physical evaluation. The cycler underwent a heater test and failed; the heater tray would not heat up. An internal inspection of the cycler found evidence of an internal short present on fuse (f1) of the ac distribution board. The ac distribution board is located in front of the power module assembly. A known good ac distribution board was installed, and the heater became operational. Removed functioning ac distribution board from the power module assembly at the completion of the investigation. An internal visual inspection of the returned cycler encountered no other discrepancies. A review of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements. The cycler was refurbished following the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[185525587]
A peritoneal dialysis (pd) patient contacted fresenius technical support to report a receiving m67 fluid temp out of range alarm during setup on the liberty cycler. The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn). A new cycler was issued to the patient. Upon follow up, the patient confirmed that there were no adverse events or medical intervention required as a result of the reported event. The patient completed treatment on the cycler. The cycler was returned to the manufacturer and a replacement cycler was provided and received. Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the fuse (f1) of the ac distribution board was identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00556 |
| MDR Report Key | 9897936 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2010-08-05 |
| Date Added to Maude | 2020-03-30 |
| 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 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 180343 |
| Catalog Number | RTLR180343 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-30 |