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 CYCLER SET, DUAL PATIENT CONNECT 050-87212 manufactured by Erika De Reynosa, S.a. De C.v..
[185972411]
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
[185972412]
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from the supply bag connection during dwell 5 of 6 of their pd treatment. The patient reported receiving an air detected in cassette alarm during dwell 5 of 6 of treatment. It is unknown at which point in therapy the leak may have begun. The cause of the leak was a loose connection. There was no fluid found on the cycler. The patient was advised to restart treatment and follow up with their peritoneal dialysis nurse (pdrn). Upon follow up, the pdrn the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event. The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated they were able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd). The patient is continuing with peritoneal dialysis on their cycler without issue and without reoccurrence of the reported event. The cassette was discarded and not available to be returned to the manufacturer for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00371 |
| MDR Report Key | 9896981 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-30 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-25 |
| Date Mfgr Received | 2020-04-01 |
| 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 | 3 |
| 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 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 1100 E, MILITARY HWY, SUITE C |
| Manufacturer City | PHARR TX 78577 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78577 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBERTY CYCLER SET, DUAL PATIENT CONNECT |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-30 |
| Model Number | 050-87212 |
| Catalog Number | 050-87212 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |