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 2020-03-27 for LIBERTY CYCLER SET, DUAL PATIENT CONNECT 050-87212 manufactured by Erika De Reynosa, S.a. De C.v..
[185975046]
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
[185975047]
It was reported that a peritoneal dialysis (pd) patient encountered a fluid leak from the cassette's second unused connector during fill 1 of pd treatment. There was no fluid leak observed within the cycler. The patient reported there were no alarms from the cycler and the cassette tubing appeared normal. The patient was advised to re-setup supplies and retain the reported cassette to return for physical evaluation by the manufacturer. Upon follow up with the peritoneal dialysis registered nurse (pdrn) the reported event could not be confirmed. The pdrn reported that she is unsure if the patient completed treatment on that data but she confirmed that the patient is trained to complete treatment with continuous ambulatory peritoneal dialysis (capd), as needed. The pdrn has seen the patient since the date of the event and confirmed that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event. The pdrn is unsure if the cassette used by the patient was available to return. A sample return kit was shipped to the patient so they can return the reported cassette to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00369 |
| MDR Report Key | 9891815 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-27 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2019-09-02 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | 050-87212 |
| Catalog Number | 050-87212 |
| Lot Number | 19LR08083 |
| 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 | 2020-03-27 |