MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE MTS SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	050-50758
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
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 a pin hole around the stay safe connector area after ending their pd treatment.The patient and patient contact wife woke up feeling the bed mattress and sheets were soaked.The patient reported receiving a cannot teach pumps during setup alarm during step 2 of setup but was able to pass on step 3.The cause of the leak is unknown.Fluid was not discovered in the pump module area or on the external of the cassette.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 not available.Upon follow up, the patient contact confirmed the reported fluid leak event occurred between the patient's pd catheter and the mts set connection.There were no other fluid leaks found at the time.The patient contact stated that per the clinic¿s procedure the patient was prescribed prophylactic antibiotics, cefazolin (1 gram, intraperitoneal, 6 hours) and ceftazadime (1 gram, intraperitoneal, 6 hours).The patient contact 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.The patient contact stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete peritoneal dialysis treatment using the cycler.The patient contact confirmed that the patient has received the replacement cycler and is continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event.The patient contact confirmed that the mts set was discarded and not available to be returned to the manufacturer for physical evaluation.
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 stay safe mts 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 a pin hole around the stay safe connector area after ending their pd treatment.The patient and patient contact wife woke up feeling the bed mattress and sheets were soaked.The patient reported receiving a cannot teach pumps during setup alarm during step 2 of setup but was able to pass on step 3.The cause of the leak is unknown.Fluid was not discovered in the pump module area or on the external of the cassette.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 not available.Upon follow up, the patient contact confirmed the reported fluid leak event occurred between the patient's pd catheter and the mts set connection.There were no other fluid leaks found at the time.The patient contact stated that per the clinic¿s procedure the patient was prescribed prophylactic antibiotics, cefazolin (1 gram, intraperitoneal, 6 hours) and ceftazadime (1 gram, intraperitoneal, 6 hours).The patient contact 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.The patient contact stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete peritoneal dialysis treatment using the cycler.The patient contact confirmed that the patient has received the replacement cycler and is continuing with peritoneal dialysis on the new cycler without issue and without reoccurrence of the reported event.The patient contact confirmed that the mts set was discarded and not available to be returned to the manufacturer for physical evaluation.

• Brand Name: STAY SAFE MTS SET
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 11886293
• Report Number: 8030665-2021-00923
• Device Sequence Number: 17071288
• Product Code: KDI
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K904806
• 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): 06/08/2021

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: 050-50758
• Device Catalogue Number: 050-50758
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER
• Patient Age: 40 YR
• Patient Weight: 70