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

Model Number CYCLER SET

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Peritoneal dialysis nurse reported to technical services during troubleshooting a patient drain complication that a fluid leak was observed by the patient inside the cycler cassette housing.It was advised to discontinue use of the cycler.Follow up with the peritoneal dialysis nurse indicates that the patient experienced abdominal pain and vomiting.The patient was not cultured but was prescribed antibiotics.The patient¿s effluent was clear.Patient has resumed treatment on a replacement cycler.

Event Description

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Manufacturer Narrative

Manufacturing plant received on 05/25/2018 an actual sample one cassette from code 050-87216 without its original package.During disinfection the alleged failure was confirmed, a leak was found on the cassette film.A visual inspection was performed to sample cassette and noticed a pin hole at the cassette film.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

• 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: 7557027
• MDR Text Key: 109765640
• Report Number: 8030665-2018-00814
• 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
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CYCLER SET
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Device Age: MO
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER; PD SOLUTION