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

Catalog Number	050-87215
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A licensed practical nurse (lpn) from a long-term care (ltc) facility reported to fresenius technical support (ts) that a fluid leak occurred during a patient's peritoneal dialysis (pd) treatment.Prior to discovery of the fluid leak, it was reported that an ¿m31 air detected in cassette¿ alarm occurred during drain 3 of 6.The lpn contacted ts for assistance in bypassing the alarm.After failing to move past the alarm, the lpn was advised to resetup the cycler with new supplies.When the lpn opened the cycler door, the fluid leak was discovered.The lpn confirmed there was no visible damage on the back of the cassette.The origin of the leak was not known.The patient did not complete their treatment.The lpn said the staff at the facility were never trained to perform manual pd exchanges as an alternative to using the cycler.The lpn was advised by ts to let the cycler dry out and wait a full 24-hours before using it again.In order to do this, the patient had to miss treatment the following day as well.However, the lpn confirmed the patient did not develop any symptoms, experience any adverse effects, injuries, or require medical intervention as a result of the reported event.The lpn confirmed the patient¿s doctor was notified, and prophylactic antibiotics were not prescribed.The patient was said to be continuing pd therapy on the same cycler without any further issues.The cycler set was not available to be returned for manufacturer evaluation as it had been discarded.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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 or Problem Description
A licensed practical nurse (lpn) from a long-term care (ltc) facility reported to fresenius technical support (ts) that a fluid leak occurred during a patient's peritoneal dialysis (pd) treatment.Prior to discovery of the fluid leak, it was reported that an ¿m31 air detected in cassette¿ alarm occurred during drain 3 of 6.The lpn contacted ts for assistance in bypassing the alarm.After failing to move past the alarm, the lpn was advised to resetup the cycler with new supplies.When the lpn opened the cycler door, the fluid leak was discovered.The lpn confirmed there was no visible damage on the back of the cassette.The origin of the leak was not known.The patient did not complete their treatment.The lpn said the staff at the facility were never trained to perform manual pd exchanges as an alternative to using the cycler.The lpn was advised by ts to let the cycler dry out and wait a full 24-hours before using it again.In order to do this, the patient had to miss treatment the following day as well.However, the lpn confirmed the patient did not develop any symptoms, experience any adverse effects, injuries, or require medical intervention as a result of the reported event.The lpn confirmed the patient¿s doctor was notified, and prophylactic antibiotics were not prescribed.The patient was said to be continuing pd therapy on the same cycler without any further issues.The cycler set was not available to be returned for manufacturer evaluation as it had been discarded.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• Common Device Name: 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: 17715830
• Report Number: 0008030665-2023-00852
• Device Sequence Number: 15140875
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K173718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 050-87215
• Device Lot Number: 22LR08065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 126 KG