MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. SAFE LOCK APD LUER LOCK CONNECTOR; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A peritoneal dialysis (pd) patient reported to fresenius technical service on 11/22/2023 that a fluid leak had occurred during their pd treatment.The patient reported the cycler had an air detected in cassette message during dwell 4 of 4 prior to the fluid leak.Two solution bags were hanging and one lying flat.Patient line, heater bag, and solution bag were securely connected.Fluid was not discovered in the pump module area, however fluid was discovered on the external of the cassette.Fluid leaked from below the connection of the last bag.Upon follow up, the peritoneal dialysis registered nurse (pdrn) confirmed the reported event through treatment data.The pdrn stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event per the treatment data.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, however could not confirm if the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).The pdrn confirmed that the patient uses the apd luer lock adapter with baxter bag as the last bag for treatment.The pdrn could not confirm if the cycler set was available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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 peritoneal dialysis (pd) patient reported to fresenius technical service on 11/22/2023 that a fluid leak had occurred during their pd treatment.The patient reported the cycler had an air detected in cassette message during dwell 4 of 4 prior to the fluid leak.Two solution bags were hanging and one lying flat.Patient line, heater bag, and solution bag were securely connected.Fluid was not discovered in the pump module area, however fluid was discovered on the external of the cassette.Fluid leaked from below the connection of the last bag.Upon follow up, the peritoneal dialysis registered nurse (pdrn) confirmed the reported event through treatment data.The pdrn stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event per the treatment data.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, however could not confirm if the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).The pdrn confirmed that the patient uses the apd luer lock adapter with baxter bag as the last bag for treatment.The pdrn could not confirm if the cycler set was available to be returned to the manufacturer for physical evaluation.

• Brand Name: SAFE LOCK APD LUER LOCK CONNECTOR
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• 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: 18222139
• Report Number: 0008030665-2023-01090
• Device Sequence Number: 20280735
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K124024
• 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): 12/21/2023

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: Lay User/Patient
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 050-95018
• Device Lot Number: 23HR08120
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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: LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 91 KG