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 Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Nausea (1970); Peritonitis (2252); Malaise (2359)

Event Date 01/03/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, fresenius became aware this male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized and was diagnosed with peritonitis.The patient reported his pd catheter (not a fresenius product) was surgically removed, and he transitioned to incenter hemodialysis (hd).No additional information was provided during intake.In the days leading up to the patient¿s hospitalization, clinical progress notes indicated the patient was complaining of shortness of breath (dyspnea) since (b)(6) 2023.The patient reported concerns his dyspnea was likely an indicator his atrial fibrillation (a-fib) had returned, and his pd registered nurse (pdrn) recommended he go to the hospital.The patient was not hospitalized, and additional clinical progress notes revealed the patient was consistently non-compliant (i.E., mircera dosing, performing treatment, clinic appointments/recommendations).Additionally, the patient refused to be assessed at the outpatient home dialysis clinic on multiple occasions, despite experiencing continued dyspnea, as well as weakness and malaise.On 3/jan/2024, the patient presented to the emergency room (er) after no ccpd therapy in 48 hours (rationale not provided), with worsening abdominal pain (3-weeks, sharp, pain scale = 9/10), diarrhea (upwards of seven stools per day), nausea, and fever.The patient¿s admission vitals included: blood pressure = 102/65, heart rate = 110 bpm, respiration rate = 16 min, temperature = 37.8 ¿ 38.2, oxygen saturation = 100% (baseline 3-liter oxygen requirement).A computed tomography (ct) scan of the patient¿s abdomen revealed possible gastritis, colonic wall thickening, fluid in the sigmoid colon, and stranding edema with mild free fluid in the abdomen or pelvis.The patient was formally admitted and diagnosed with peritonitis and clostridium difficile.The patient was treated with oral vancomycin, intravenous (iv) cefepime, and iv flagyl (doses, frequency, duration not provided).On (b)(6) 2024, the patient underwent the surgical placement of a hemodialysis (hd) catheter (not a fresenius product) and was transitioned to hd for rrt the same day.The hpm reported the patient transitioned to hd because he no longer wanted to perform pd therapy at home.The remainder of the patient¿s hospitalization was unremarkable; however, it should be noted the patient¿s hemoglobin dropped to 5.9 g/l (cause not provided) and he was transfused with 2 units of packed red blood cells (hemoglobin increased to 8.3 g/l).The patient was discharged on (b)(6) 2024 in stable condition and will begin incenter hd on (b)(6) 2024.Upon discharge, the patient¿s antibiotic regimen was changed to iv vancomycin 500 mg post hd 3 times-a-week, iv ceftazidime 1000 mg post hd 3 times-a-week, and oral flagyl 500 mg twice daily until (b)(6) 2024 due to culture negative pd catheter (not a fresenius product) associated peritonitis.Additionally, the patient¿s oral vancomycin continued for 10 days due to the clostridium difficile infection.Per the documentation provided, the patient has recovered from the serious adverse events.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the serious adverse events of a clostridium difficile infection and sterile peritonitis (characterized by weakness, malaise, nausea, abdominal pain, fever, and diarrhea), which required hospitalization and antibiotic therapy.The etiology of either infection is unknown; therefore, causality could not be firmly established.However, per the pdrn¿s response, the patient transitioned to hd due to personal preference, and not due to any fresenius device(s) and/or product(s) deficiency or malfunction.Those individuals undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.Additionally, clostridium difficile infections in pd patients being treated for peritonitis frequently require longer durations of antibiotics and multiple changes in the antibiotic regimen.Based on the information available, the patient¿s liberty select cycler and liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there is no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or the manufacturers¿ specifications.

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.

Event Description

On (b)(6) 2024, fresenius became aware this male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized and was diagnosed with peritonitis.The patient reported his pd catheter (not a fresenius product) was surgically removed, and he transitioned to incenter hemodialysis (hd).No additional information was provided during intake.In the days leading up to the patient¿s hospitalization, clinical progress notes indicated the patient was complaining of shortness of breath (dyspnea) since (b)(6) 2023.The patient reported concerns his dyspnea was likely an indicator his atrial fibrillation (a-fib) had returned, and his pd registered nurse (pdrn) recommended he go to the hospital.The patient was not hospitalized, and additional clinical progress notes revealed the patient was consistently non-compliant (i.E., mircera dosing, performing treatment, clinic appointments/recommendations).Additionally, the patient refused to be assessed at the outpatient home dialysis clinic on multiple occasions, despite experiencing continued dyspnea, as well as weakness and malaise.On (b)(6) 2024, the patient presented to the emergency room (er) after no ccpd therapy in 48 hours (rationale not provided), with worsening abdominal pain (3-weeks, sharp, pain scale = 9/10), diarrhea (upwards of seven stools per day), nausea, and fever.The patient¿s admission vitals included: blood pressure = 102/65, heart rate = 110 bpm, respiration rate = 16 min, temperature = 37.8 ¿ 38.2, oxygen saturation = 100% (baseline 3-liter oxygen requirement).A computed tomography (ct) scan of the patient¿s abdomen revealed possible gastritis, colonic wall thickening, fluid in the sigmoid colon, and stranding edema with mild free fluid in the abdomen or pelvis.The patient was formally admitted and diagnosed with peritonitis and clostridium difficile.The patient was treated with oral vancomycin, intravenous (iv) cefepime, and iv flagyl (doses, frequency, duration not provided).On (b)(6) 2024, the patient underwent the surgical placement of a hemodialysis (hd) catheter (not a fresenius product) and was transitioned to hd for rrt the same day.The hpm reported the patient transitioned to hd because he no longer wanted to perform pd therapy at home.The remainder of the patient¿s hospitalization was unremarkable; however, it should be noted the patient¿s hemoglobin dropped to 5.9 g/l (cause not provided) and he was transfused with 2 units of packed red blood cells (hemoglobin increased to 8.3 g/l).The patient was discharged on (b)(6) 2024 in stable condition and will begin incenter hd on (b)(6) 2024.Upon discharge, the patient¿s antibiotic regimen was changed to iv vancomycin 500 mg post hd 3 times-a-week, iv ceftazidime 1000 mg post hd 3 times-a-week, and oral flagyl 500 mg twice daily until (b)(6) 2024 due to culture negative pd catheter (not a fresenius product) associated peritonitis.Additionally, the patient¿s oral vancomycin continued for 10 days due to the clostridium difficile infection.Per the documentation provided, the patient has recovered from the serious adverse events.

• 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: 18512682
• MDR Text Key: 332901994
• Report Number: 0008030665-2024-00049
• Device Sequence Number: 1
• Product Code: FKX
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/06/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 54 KG