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

Model 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	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid dripping from the last bag onto their floor during dwell 5 of 5 of their pd treatment.The patient reported receiving an air detected in cassette alarm prior to discovering the leak.The cause of the leak is unknown.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed the reported fluid leak event.The patient stated that the fluid leak occurred on (b)(6) 2021.There were air detected in cassette messages during dwell 5 of 5 of treatment and upon looking around, the patient noticed that the luer lock connector was leaking onto their floor.The patient stated that the tubing of the luer lock connecter was leaking and confirmed that no fluid got in or near the cycler and had only gotten onto their floor.The patient stated that the baxter bag was not leaking or damaged and confirmed that only the luer lock connector was leaking.The patient stated that the tubing was leaking, but they could not find the hole it was leaking from.The cause of the leak was unknown.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported events.The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and was able to complete peritoneal dialysis treatment manually on the night of the reported event.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
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 dripping from the last bag onto their floor during dwell 5 of 5 of their pd treatment.The patient reported receiving an air detected in cassette alarm prior to discovering the leak.The cause of the leak is unknown.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed the reported fluid leak event.The patient stated that the fluid leak occurred on 12/23/2021.There were air detected in cassette messages during dwell 5 of 5 of treatment and upon looking around, the patient noticed that the luer lock connector was leaking onto their floor.The patient stated that the tubing of the luer lock connecter was leaking and confirmed that no fluid got in or near the cycler and had only gotten onto their floor.The patient stated that the baxter bag was not leaking or damaged and confirmed that only the luer lock connector was leaking.The patient stated that the tubing was leaking, but they could not find the hole it was leaking from.The cause of the leak was unknown.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported events.The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and was able to complete peritoneal dialysis treatment manually on the night of the reported event.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
Additional Manufacturer Narrative
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.

• 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; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13097102
• Report Number: 8030665-2021-01918
• Device Sequence Number: 2047085
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/21/2022

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 Model Number: 050-95018
• 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: 12/23/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/21/2022
• 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 SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTIONS; PD SOLUTIONS
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 74 KG