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 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient reported that there was a fluid leak during pd treatment.When the cassette was removed there was fluid on the sensor.In a follow up, a pd nurse verified the event and said the fluid was discovered upon treatment completion when the patient was removing the cycler set from the cassette compartment of the liberty select cycler.The patient inspected the cycler set.No defect or damage was noted.Adrina stated that the patient was prescribed prophylactic antibiotic ciprofloxacin (250 mg, oral, three times daily for three days).Adrina confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.Adrina confirmed the cycler remained with the patient for continued use.The patient dried out the cassette compartment of the cycler and planned to continue using.The cassette is available to return as a sample.

• 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: 19003799
• MDR Text Key: 339096596
• Report Number: 0008030665-2024-00313
• 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,Health Professional,User Facility,Company Representative
• 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: 03/29/2024
• 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: 23DR08111
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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 CYCLER SET
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 107 KG