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	04/12/2024
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
It was reported that a peritoneal dialysis registered nurse (pdrn) discovered a fluid leak on the bottom area of the cassette door of the cycler during drain 3 of 4 and also at the end of the pd treatment.The patient reported receiving an air detected in cassette alarm prior to the leak.The cause of the leak is unknown.Fluid was discovered in the pump module area and on the external of the cassette.The pdrn was advised to disregard the use of the cycler until the next day and follow up with the patient's on-call pdrn.It was reported that an alternate treatment option was available.Upon follow up, the pdrn confirmed the reported event, and that fluid was found underneath the cycler as well.The pdrn stated that per the clinic¿s procedure the patient was prescribed prophylactic antibiotics (type unknown, dose unknown, oral, three days).The pdrn 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.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The pdrn confirmed that the cycler has not been used since the event.The pdrn confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.
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
It was reported that a peritoneal dialysis registered nurse (pdrn) discovered a fluid leak on the bottom area of the cassette door of the cycler during drain 3 of 4 and also at the end of the pd treatment.The patient reported receiving an air detected in cassette alarm prior to the leak.The cause of the leak is unknown.Fluid was discovered in the pump module area and on the external of the cassette.The pdrn was advised to disregard the use of the cycler until the next day and follow up with the patient's on-call pdrn.It was reported that an alternate treatment option was available.Upon follow up, the pdrn confirmed the reported event, and that fluid was found underneath the cycler as well.The pdrn stated that per the clinic¿s procedure the patient was prescribed prophylactic antibiotics (type unknown, dose unknown, oral, three days).The pdrn 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.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The pdrn confirmed that the cycler has not been used since the event.The pdrn confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
It was reported that a peritoneal dialysis registered nurse (pdrn) discovered a fluid leak on the bottom area of the cassette door of the cycler during drain 3 of 4 and also at the end of the pd treatment.The patient reported receiving an air detected in cassette alarm prior to the leak.The cause of the leak is unknown.Fluid was discovered in the pump module area and on the external of the cassette.The pdrn was advised to disregard the use of the cycler until the next day and follow up with the patient's on-call pdrn.It was reported that an alternate treatment option was available.Upon follow up, the pdrn confirmed the reported event, and that fluid was found underneath the cycler as well.The pdrn stated that per the clinic¿s procedure the patient was prescribed prophylactic antibiotics (type unknown, dose unknown, oral, three days).The pdrn 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.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The pdrn confirmed that the cycler has not been used since the event.The pdrn confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Correction: h6 health effect impact code 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.

• 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: 19110900
• Report Number: 0008030665-2024-00362
• Device Sequence Number: 12819419
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2024

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: Lay User/Patient
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 050-87215
• Device Lot Number: 23DR08122
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 08/26/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/08/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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.; DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.
• Patient Age: 40 YR
• Patient Sex: Male