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); Peritonitis (2252); Constipation (3274)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between ccpd therapy utilizing a liberty select cycler, liberty cycler set and the serious adverse events of constipation, enteritis, and peritonitis (characterized by abdominal pain and cloudy peritoneal effluent fluid), which warranted hospitalization and antibiotic therapy.Causality was attributed to the transmural migration of bacteria from the bowel to the peritoneum, due to constipation and enteritis.Per the pdrn, the events were unrelated to the patient¿s utilization of any fresenius product(s) and/or device(s).Escherichia coli is one of the most common organisms causing gram-negative peritonitis in pd patients and is considered normal flora of the gastrointestinal tract.Additionally, studies have shown preventing constipation greatly reduces the risk of contracting peritonitis due to the migration of bacteria into the peritoneum.Based on the information available, the liberty select cycler and liberty cycler set can be disassociated from the 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 was no report a fresenius device(s) and/or product(s) failed to meet users¿ expectations or manufacturers¿ specifications.Those individuals undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.

Event Description

On 7/mar/2024 during follow-up for file (b)(4), fresenius became aware this 62-year-old 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) contracted enteritis and peritonitis due to prolonged constipation.Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the emergency room on (b)(6) 2023 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (results not provided) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) vancomycin and cefazolin (dose, duration, frequency not provided).The patient¿s peritoneal effluent culture result returned positive for escherichia coli on 9/dec/2023, and the patient¿s vancomycin was replaced with oral ciprofloxacin (dose, duration, frequency not provided).The patient¿s abdominal pain and cloudy peritoneal effluent fluid have resolved, and he has recovered from the serious adverse events.The pdrn attributed causality to the transmural migration of bacteria from the bowel to the peritoneum, due to prolonged constipation and enteritis.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.At the time, the patient continued to undergo ccpd therapy utilizing the same liberty select cycler without reported complaint.

Event Description

On (b)(6) 2024 during follow-up for file (b)(4), fresenius became aware this 62-year-old 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) contracted enteritis and peritonitis due to prolonged constipation.Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the emergency room on (b)(6) 2023 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (results not provided) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) vancomycin and cefazolin (dose, duration, frequency not provided).The patient¿s peritoneal effluent culture result returned positive for escherichia coli on (b)(6) 2023, and the patient¿s vancomycin was replaced with oral ciprofloxacin (dose, duration, frequency not provided).The patient¿s abdominal pain and cloudy peritoneal effluent fluid have resolved, and he has recovered from the serious adverse events.The pdrn attributed causality to the transmural migration of bacteria from the bowel to the peritoneum, due to prolonged constipation and enteritis.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.At the time, the patient continued to undergo ccpd therapy utilizing the same liberty select cycler without reported complaint.

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.

Manufacturer Narrative

Upon receipt of additional information, it was determined that the event reported in mfr 8030665-2024-00252 was related to prolonged constipation, and is not a reportable event related to fmcrtg products.There will be no further updates on 8030665-2024-00252.

Event Description

On 7/mar/2024 during follow-up for file (b)(4), fresenius became aware this 62-year-old 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) contracted enteritis and peritonitis due to prolonged constipation.Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the emergency room on (b)(6) 2023 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (results not provided) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) vancomycin and cefazolin (dose, duration, frequency not provided).The patient¿s peritoneal effluent culture result returned positive for escherichia coli on (b)(6) 2023, and the patient¿s vancomycin was replaced with oral ciprofloxacin (dose, duration, frequency not provided).The patient¿s abdominal pain and cloudy peritoneal effluent fluid have resolved, and he has recovered from the serious adverse events.The pdrn attributed causality to the transmural migration of bacteria from the bowel to the peritoneum, due to prolonged constipation and enteritis.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.At the time, the patient continued to undergo ccpd therapy utilizing the same liberty select cycler without reported complaint.

• 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: 18876070
• MDR Text Key: 337340259
• Report Number: 0008030665-2024-00252
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/21/2024; Not provided
• Supplement Dates FDA Received: 03/21/2024; 04/19/2024
• 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: LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTION; PD SOLUTION; PD SOLUTION
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male