MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-30 for LIBERTY SELECT CYCLER ASSY(NON-VALUATED) 180343 RTLR180343 manufactured by Concord Manufacturing.
[185516154]
Plant investigation: the actual device was returned to the manufacturer for physical evaluation. An exterior visual inspection of the returned cycler showed no signs of physical damage. The cycler touch screen test failed. When powering on the cycler, the ok, stop and up/down arrow push buttons illuminated, however the front panel touch screen remained blank. The cycler underwent and passed the touch screen calibration test. The display was dim, but the touch screen calibration was in specification. It was identified that the cause for the blank screen was due to an internal short present transformer (t1) on the inverter board. A known good inverter board was installed and the display became fully operational. 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. Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be an internal short on transformer on the inverter board. The cycler was refurbished following the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[185516155]
It was reported that the patient? S liberty select cycler touch screen was having problems during step 8 of their peritoneal dialysis (pd) end treatment. At that point in time, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event. A replacement cycler was issued to the patient. It was reported that an alternate treatment option was not available. Upon follow up, the pdrn confirmed that there were no adverse events or medical intervention required as a result of the reported event. The patient did not complete treatment. 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 transformer on the inverter board was identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00555 |
| MDR Report Key | 9897699 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2015-10-02 |
| 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 | 2020-03-06 |
| 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 |