MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for LIBERTY CYCLER SET, SINGLE CONN./EXT. DL 050-87216 manufactured by Erika De Reynosa, S.a. De C.v..
[185969881]
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided. A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date. This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame. The entire set of lots have been sold and distributed. There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event. An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements. The product lots involved met all specifications for release. A review of the dhr did not reveal a probable cause for the customer complaint. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[185969882]
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the inside of the cassette door of their cycler after ending their pd treatment. The patient reported receiving an air detected in cassette alarm during fill 1 of 5 of 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 stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler. The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event. The patient has received a new cycler which is working well and is continuing peritoneal dialysis therapy with no further issues. The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer. The cycler was returned to the manufacturer for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00377 |
| MDR Report Key | 9903319 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| 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 | 2020-03-31 |