MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. UNKNOWN- FMC PRODUCT; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number	050-95003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from the patient¿s catheter during their cycler after ending their pd 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 follow up with their peritoneal dialysis nurse (pdrn).Upon follow up, the pdrn stated that the cause of the leak was a hole in the plastic adapter.The patient was seen in the clinic where the tubing of the adapter was cut and replaced.Confirmed that fluid did not come in contact with the cycler.Per the clinic¿s procedure the patient was prescribed prophylactic antibiotics, cephalexin (250 milligrams, oral, three times a day for three days) confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.Confirmed that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient is continuing peritoneal dialysis therapy with no further issues.The adapter 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. .
Additional Manufacturer Narrative
Correction provided in d1, d4, and g4.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.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from the patient¿s catheter during their pd 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 follow up with their peritoneal dialysis nurse (pdrn).Upon follow up, the pdrn stated that the cause of the leak was a hole in the plastic adapter.The patient was seen in the clinic where the tubing of the adapter was cut and replaced.Confirmed that fluid did not come in contact with the cycler.Per the clinic¿s procedure the patient was prescribed prophylactic antibiotics, cephalexin (250 milligrams, oral, three times a day for three days) confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.Confirmed that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient is continuing peritoneal dialysis therapy with no further issues.The adapter used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
Additional Manufacturer Narrative
Correction provided in b5.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak from the patient¿s catheter during their pd 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 follow up with their peritoneal dialysis nurse (pdrn).Upon follow up, the pdrn stated that the cause of the leak was a hole in the plastic adapter.The patient was seen in the clinic where the tubing of the adapter was cut and replaced.Confirmed that fluid did not come in contact with the cycler.Per the clinic¿s procedure the patient was prescribed prophylactic antibiotics, cephalexin (250 milligrams, oral, three times a day for three days) confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.Confirmed that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient is continuing peritoneal dialysis therapy with no further issues.The adapter used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.

• Brand Name: UNKNOWN- FMC PRODUCT
• 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: 17298928
• Report Number: 0008030665-2023-00617
• Device Sequence Number: 3864172
• Product Code: FKX
• UDI-Device Identifier: 00840861100774
• UDI-Public: 00840861100774
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173718
• 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,Followup
• Report Date (Section B): 08/22/2023
• 2 Devices were Involved in the Event: 1 2

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: 050-95003
• Device Catalogue Number: UNKNOWN-FMCPRODUCT
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 08/09/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/07/2023; 08/22/2023
• 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; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Age: 81 YR
• Patient Sex: Male