MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number UNKNOWN- FMC CASSETTE

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

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 drain 2 of 4 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.Air bubbles were reported in the cassette tubing.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 pdrn 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 clinic has received a new cycler with no further issues.The cassette used was discarded and is not available for return for physical evaluation by the manufacturer.The cycler is scheduled to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

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.

Event Description

It was reported that a peritoneal dialysis registered nurse (pdrn) discovered a fluid leak on the inside of the cassette door of the cycler after ending the patient's pd treatment.The pdrn reported receiving an air detected in cassette alarm during drain 2 of 4 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.Air bubbles were reported in the cassette tubing.The contact pdrn was advised to discontinue the use of the cycler.A new cycler was issued to the clinic.It was reported that an alternate treatment option was available.Upon follow up, the pdrn 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 clinic has received a new cycler with no further issues.The cassette used was discarded and is not available for return for physical evaluation by the manufacturer.The cycler is scheduled to be returned to the manufacturer for physical evaluation.

• Brand Name: FMC CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 8560194
• MDR Text Key: 143400426
• Report Number: 8030665-2019-00653
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER; DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Age: 55 YR
• Patient Weight: 79