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 CYCLER SET, SINGLE PATIENT CONN 050-87215 manufactured by Erika De Reynosa, S.a. De C.v..
[185971782]
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
[185971783]
It was reported that a peritoneal dialysis (pd) patient experienced a please check heater, patient and drain line alarm during fill 1 of 4 of treatment. The patient had an issue in a prior setup and decided to re-setup with the same supplies. The patient could not access diagnostics to verify what alarm they encountered. Technical support advised to re-setup with new supplies. Upon follow up, the patient stated being able to complete treatment with another bag and new supplies. The patient confirmed that the leak occurred inside the cassette door and fluid poured out when removing the cassette. 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 being able to complete peritoneal dialysis treatment using new supplies with the original cycler. The patient is continuing with peritoneal dialysis on the original cycler without issue and without reoccurrence of the reported event. The patient confirmed that 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 | 8030665-2020-00373 |
| MDR Report Key | 9900590 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-30 |
| 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, SINGLE PATIENT CONN |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-30 |
| Model Number | 050-87215 |
| Catalog Number | 050-87215 |
| 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 |