MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-27 for LIBERTY CYCLER SET, SINGLE CONN./EXT. DL 050-87216 manufactured by Erika De Reynosa, S.a. De C.v..
[185975304]
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
[185975305]
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak when removing the cassette from their cycler after ending their pd treatment. The patient reported receiving an air detected in cassette alarm twice during treatment and the treatment was cancelled. It is unknown at which point in therapy the leak may have begun. The cause of the leak is unknown. 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. It was reported that an alternate treatment option was available. Upon follow up, the patient contact confirmed the reported fluid leak event occurred during drain 3 and originated from inside the cassette door. The patient contact stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, however the patient skipped peritoneal dialysis treatment in the absence of the cycler. The patient contact confirmed that the patient has received the replacement cycler. The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer. The original cycler is available to be returned to the manufacturer for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00364 |
| MDR Report Key | 9891475 |
| Report Source | CONSUMER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-25 |
| Date Mfgr Received | 2020-04-01 |
| 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, SINGLE CONN./EXT. DL |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-27 |
| Model Number | 050-87216 |
| Catalog Number | 050-87216 |
| 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 |