MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87212

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2024

Event Type  malfunction  

Event Description

It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak during their pd treatment.The patient reported receiving a filling slowly 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.Fluid was not discovered in the pump module area or on the external of the cassette.The patient was advised to follow up with their peritoneal dialysis nurse (pdrn).It was reported that an alternate treatment option was not available.Upon follow up, the patient confirmed that the blue patient line tubing on the cycler set had a leak.There were no fluid leaks on the solution bag or connection.Additionally, no fluid was detected in or around 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 skipped the remainder of peritoneal dialysis treatment in the absence of the cycler.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

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

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18994147
• MDR Text Key: 338892278
• Report Number: 0008030665-2024-00310
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Device Lot Number: 22PR08048
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 82 KG