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

Model Number	050-50758
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A peritoneal dialysis (pd) patient contacted fresenius technical support to report the liberty select cycler alarmed with an m31 air detected in cassette warning during drain 1 of 5.A fluid leak was subsequently discovered in step 9 of treatment complete.The patient was not connected during the incident.Fluid was found in both the pump module area and on the external portion of the cassette.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.Upon followup the clinic manager (cm) at the patient¿s clinic confirmed the reported event.The cm stated that patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The cm could not confirm if the patient completed treatment on the day of the reported event.The cm confirmed the patient has continued using the cycler for their pd treatment without issue since.The cm confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.No defect or damage to the cycler set cassette was noted upon removing it from the cycler.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Correction: d1, d4, g4 pma/510(k)#, h4 plant investigation: 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 or Problem Description
A peritoneal dialysis (pd) patient contacted fresenius technical support to report the liberty select cycler alarmed with an m31 air detected in cassette warning during drain 1 of 5.A fluid leak was subsequently discovered in step 9 of treatment complete.The patient was not connected during the incident.Fluid was found in both the pump module area and on the external portion of the cassette.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.Upon followup the clinic manager (cm) at the patient¿s clinic confirmed the reported event.The cm stated that patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The cm could not confirm if the patient completed treatment on the day of the reported event.The cm confirmed the patient has continued using the cycler for their pd treatment without issue since.The cm confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.No defect or damage to the cycler set cassette was noted upon removing it from the cycler.

• Brand Name: FMC CASSETTE
• 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: 17243830
• Report Number: 0008030665-2023-00588
• Device Sequence Number: 20148576
• Product Code: FKX
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2025
• Device Model Number: 050-50758
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Device Lot Number: 22SR08083
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 72 KG