MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-30 for FMC CASSETTE UNKNOWN- FMC CASSETTE manufactured by Erika De Reynosa, S.a. De C.v..
[185971524]
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
[185971525]
It was reported that a peritoneal dialysis (pd) patient utilizing a liberty select cycler at a rehab center experienced a fluid leak which was observed coming out of the cycler's cassette compartment door during fill 2 of 5. The registered nurse (rn) reported that the cycler was alarming patient line is blocked during fill 2 of 5. It was indicated that there was fluid within the cycler. The cassette setup was reviewed with technical support and it was noted that the likely cause of the patient line is blocked alarm was that the patient line was clamped after noticing the fluid leak. The rn was advised the clamp all the lines and power down the cycler. A replacement cycler was issued and the reported cycler was scheduled to be picked up and returned to the manufacturer for physical evaluation. The rn was advised to contact the peritoneal dialysis registered nurse (pdrn). It was indicated that an alternate treatment plan was available. Upon follow up with the rn, it as indicated that an on-call pdrn arrived at the clinic, checked the machine, and could not identify a cause for the leak. The patients treatment was continued on the pd cycler. The rn was unsure if the cassette and solution bags were re-setup or replaced. The rn could not confirm if the patient was able to complete treatment. Patient's record were unavailable and the rn could not provide patient details, status of the cycler return, status of the cycler replacement, nor the status of the reported cassette. There was no adverse event, symptoms, nor medical intervention indicated to have been caused by the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00372 |
| MDR Report Key | 9900200 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| 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 | FMC CASSETTE |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-30 |
| Catalog Number | UNKNOWN- FMC CASSETTE |
| Operator | HEALTH PROFESSIONAL |
| 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 |