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	SAFE LOCK APD LUER LOCK CONNECTOR
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
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 from the green clamp line during their pd treatment.It was reported that the connection may have been slightly loose.The patient reported receiving a supply bag lines are blocked message during dwell 5 of 5 of treatment.It is unknown at which point in therapy the leak may have begun.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).Upon follow up, the patient stated that they received an air detected in cassette message and supply bag lines are blocked message during dwell 5 of 5 and upon looking around to see what was causing the alarm the patient noticed that the baxter bag was disconnected and leaking.The patient stated that they were not sure why the baxter bag came disconnected.The patient stated that no fluid got in or near the cycler.The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that they were able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from the green clamp line during their pd treatment.It was reported that the connection may have been slightly loose.The patient reported receiving a supply bag lines are blocked message during dwell 5 of 5 of treatment.It is unknown at which point in therapy the leak may have begun.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).Upon follow up, the patient stated that they received an air detected in cassette message and supply bag lines are blocked message during dwell 5 of 5 and upon looking around to see what was causing the alarm the patient noticed that the baxter bag was disconnected and leaking.The patient stated that they were not sure why the baxter bag came disconnected.The patient stated that no fluid got in or near the cycler.The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that they were able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result 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
Corrections: d10 additional information: g1 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14340564
• Report Number: 0008030665-2022-00528
• Device Sequence Number: 14752210
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/01/2022

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: SAFE LOCK APD LUER LOCK CONNECTOR
• Device Catalogue Number: 050-95018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/01/2022
• 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: DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Sex: Unknown