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	11/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A peritoneal dialysis (pd) patient's caregiver reported a fluid leak discovered from a baxter bag connection during dwell 4 of 4 of treatment.The contact reported the cycler prompted with an m31 air detected in cassette warning message during dwell 4 of 4 of treatment and prior to the observation of the fluid leak.The patient was connected during the incident.Fluid was fluid was not discovered in the pump module area or on the external of the cassette.Fluid leaked from a baxter bag connection.Treatment was cancelled and the patient knew how to perform continuous ambulatory peritoneal dialysis (capd) therapy.Upon follow-up, the contact confirmed the reported event and stated the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The contact stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed and completed peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) the following morning via two manual exchanges.The contact stated the patient used an apd luer lock adapter with a baxter solution bag as the last bag for treatment and noted fluid leaking from the connection between the adapter and solution bag.Solution was found on the floor by the cycler cart.The contact stated the patient was able to resume use of the cycler the following treatment without further issue.The contact stated the adapter and baxter bag were discarded and were no longer available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A peritoneal dialysis (pd) patient's caregiver reported a fluid leak discovered from a baxter bag connection during dwell 4 of 4 of treatment.The contact reported the cycler prompted with an m31 air detected in cassette warning message during dwell 4 of 4 of treatment and prior to the observation of the fluid leak.The patient was connected during the incident.Fluid was fluid was not discovered in the pump module area or on the external of the cassette.Fluid leaked from a baxter bag connection.Treatment was cancelled and the patient knew how to perform continuous ambulatory peritoneal dialysis (capd) therapy.Upon follow-up, the contact confirmed the reported event and stated the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The contact stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed and completed peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) the following morning via two manual exchanges.The contact stated the patient used an apd luer lock adapter with a baxter solution bag as the last bag for treatment and noted fluid leaking from the connection between the adapter and solution bag.Solution was found on the floor by the cycler cart.The contact stated the patient was able to resume use of the cycler the following treatment without further issue.The contact stated the adapter and baxter bag were discarded and were no longer available to be returned for manufacturer evaluation.
Event or Problem Description
A peritoneal dialysis (pd) patient's caregiver reported a fluid leak discovered from a baxter bag connection during dwell 4 of 4 of treatment.The contact reported the cycler prompted with an m31 air detected in cassette warning message during dwell 4 of 4 of treatment and prior to the observation of the fluid leak.The patient was connected during the incident.Fluid was fluid was not discovered in the pump module area or on the external of the cassette.Fluid leaked from a baxter bag connection.Treatment was cancelled and the patient knew how to perform continuous ambulatory peritoneal dialysis (capd) therapy.Upon follow-up, the contact confirmed the reported event and stated the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The contact stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed and completed peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) the following morning via two manual exchanges.The contact stated the patient used an apd luer lock adapter with a baxter solution bag as the last bag for treatment and noted fluid leaking from the connection between the adapter and solution bag.Solution was found on the floor by the cycler cart.The contact stated the patient was able to resume use of the cycler the following treatment without further issue.The contact stated the adapter and baxter bag were discarded and were no longer available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.No product will be returned from the distribution center to be analyzed since the lot number is unknown and no information was found on the system from this patient regarding to safe lock apd luer lock connector product been delivered.Since the complaint sample is not available for evaluation neither photos or videos were provided for evaluation and dhr review was not performed since the lot number is unknown and no information was found on the sap system, the alleged event could not be confirmed.At this time, no sample has been provided.Should the sample become available, the investigation file will be reopened and will be updated accordingly.

• 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: 18220644
• Report Number: 0008030665-2023-01086
• Device Sequence Number: 6721968
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2024

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 Catalogue Number: 050-95018
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2023
• Supplement Date Received by Manufacturer: 02/05/2024; 02/07/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 02/05/2024; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Sex: Male