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	01/17/2024
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 (pd) patient discovered a fluid leak on the connection to the last bag during their pd treatment.The patient reported receiving an air detected in cassette alarm during dwell 4 of 4 of treatment.The patient reported the last bag connection was not tight enough.Fluid was also seen on the cart shelf.Fluid was not discovered in the pump module area or on the external of the cassette.The patient was advised on how to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed the reported fluid leak event occurred at the connection between the safe lock adapter and baxter bag during the last fill of treatment.The patient tightened the connection as much as possible, but it still felt as if it was not fully tightened.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient skipped the remainder of peritoneal dialysis treatment in the absence of the cycler.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient confirmed that the adapter and bag were discarded and not available to be returned to the manufacturers 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-conformance's 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 (pd) patient discovered a fluid leak on the connection to the last bag during their pd treatment.The patient reported receiving an air detected in cassette alarm during dwell 4 of 4 of treatment.The patient reported the last bag connection was not tight enough.Fluid was also seen on the cart shelf.Fluid was not discovered in the pump module area or on the external of the cassette.The patient was advised on how to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed the reported fluid leak event occurred at the connection between the safe lock adapter and baxter bag during the last fill of treatment.The patient tightened the connection as much as possible, but it still felt as if it was not fully tightened.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient skipped the remainder of peritoneal dialysis treatment in the absence of the cycler.The patient is continuing with peritoneal dialysis on the cycler without issue and without reoccurrence of the reported event.The patient confirmed that the adapter and bag were discarded and not available to be returned to the manufacturers 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: 18539269
• Report Number: 0008030665-2024-00064
• Device Sequence Number: 6402627
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 02/09/2024

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: 08/31/2024
• Device Catalogue Number: 050-95018
• Device Lot Number: 23KR08109
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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: 87 YR
• Patient Sex: Male
• Patient Weight: 86 KG