MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Peritonitis (2252)

Event Date 04/15/2024

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is a temporal relationship between peritoneal dialysis utilizing the liberty select cycler with liberty cycler set and the patient event of peritonitis.However, there is no documentation in the complaint file to show a causal relationship between the peritonitis and use of the cycler or cycler set.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.The pd cultures were negative for growth.Not all pd fluid cultures always yield an organism in patients with clinical findings of peritonitis.Although a cause could not be determined, touch contamination is the primary cause of peritonitis with the pd catheter being the source of infection for most pd-related cases of peritonitis.Based on the available information and no allegation of a malfunction, deficiency, or defect, the liberty select cycler and cycler set can be excluded as the cause of the patient¿s peritonitis event.

Event Description

On (b)(6) 2024 this peritoneal dialysis (pd) patient contacted fresenius technical support for draining slowly messages over the last week during treatment on the liberty select cycler.The patient advised she was diagnosed with an infection and was started on antibiotics.Additional information was obtained through follow-up with the patient.The patient stated the unspecified infection was peritonitis.The patient was being treated with antibiotics.The patient also reported that on (b)(6) 2024 she had the pd catheter (not a fresenius product) replaced.Further details pertaining to the patient¿s peritonitis event were obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient presented to the pd clinic on (b)(6) 2024 with cloudy pd fluid and complaints of diarrhea.A pd effluent culture was obtained.The patient was initiated on intraperitoneal (ip) antibiotics (drug, dose, frequency, and duration not provided).The patient was diagnosed with peritonitis.The patient¿s white blood cell count (wbc) was elevated to 2,844.After five days, the pd culture shows no organism growth, but a high white cell count.The cause of the peritonitis is unknown.The only issue the patient reported was poor drains.The patient had a pd catheter (not a fresenius product) revision (not a replacement as the patient reported) completed on (b)(6) 2024.The patient did not report any fluid leak or other issue with the liberty select cycler or cycler set related to this event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

On (b)(6) 2024 this peritoneal dialysis (pd) patient contacted fresenius technical support for draining slowly messages over the last week during treatment on the liberty select cycler.The patient advised she was diagnosed with an infection and was started on antibiotics.Additional information was obtained through follow-up with the patient.The patient stated the unspecified infection was peritonitis.The patient was being treated with antibiotics.The patient also reported that on (b)(6) 2024 she had the pd catheter (not a fresenius product) replaced.Further details pertaining to the patient¿s peritonitis event were obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient presented to the pd clinic on (b)(6) 2024 with cloudy pd fluid and complaints of diarrhea.A pd effluent culture was obtained.The patient was initiated on intraperitoneal (ip) antibiotics (drug, dose, frequency, and duration not provided).The patient was diagnosed with peritonitis.The patient¿s white blood cell count (wbc) was elevated to 2,844.After five days, the pd culture shows no organism growth, but a high white cell count.The cause of the peritonitis is unknown.The only issue the patient reported was poor drains.The patient had a pd catheter (not a fresenius product) revision (not a replacement as the patient reported) completed on (b)(6) 2024.The patient did not report any fluid leak or other issue with the liberty select cycler or cycler set related to this event.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• 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: 19174730
• MDR Text Key: 340951115
• Report Number: 0008030665-2024-00398
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female