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)

Event Date 01/21/2024

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the adverse events of peritonitis, characterized by abdominal pain and cloudy peritoneal effluent fluid, which warranted hospitalization and ip antibiotic therapy.Causality was attributed to multiple cats at the sons¿ residence (visiting) being present for initiation and termination of ccpd therapy.Per the pdrn, the serious adverse events were not related to the patient¿s utilization of any fresenius device(s) and/or product(s).Pasteurella bacteria are known inhabitants of the upper respiratory tract in canines/felines and can be transmitted to humans through direct and indirect contact.Based on the information available, the 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 and/or contributed to the serious adverse events.Additionally, there was no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or manufacturers¿ specifications.Those individuals undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was diagnosed with peritonitis.No additional information was provided during intake.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the outpatient home dialysis clinic with abdominal pain and cloudy peritoneal effluent fluid on (b)(6) 2024.A peritoneal effluent fluid culture and cell count (wbc = >5,000 g/dl) were collected, and the patient was diagnosed with peritonitis.The patient was initially treated with intraperitoneal (ip) vancomycin and ceftazidime (dosages, frequencies, durations not provided).However, the peritoneal effluent cultures returned positive for pasteurella multocida on (b)(6) 2024, and the patient¿s ip vancomycin and ceftazidime were discontinued.The patient was transitioned to daily ip augmentin (dosage, duration not provided).The pdrn stated the patient was visiting his son when he contracted the infection.The pdrn attributed causality to multiple cats at the sons¿ residence being present for initiation and termination of ccpd therapy.The patient has been reeducated.The patient has recovered from the serious adverse events and continues to utilize the same cycler.Per the patient¿s pdrn, the reported serious adverse events were unrelated to the patient¿s utilization of any device(s) and/or product(s).

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

A peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was diagnosed with peritonitis.No additional information was provided during intake.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the outpatient home dialysis clinic with abdominal pain and cloudy peritoneal effluent fluid on 21/jan/2024.A peritoneal effluent fluid culture and cell count (wbc = >5,000 g/dl) were collected, and the patient was diagnosed with peritonitis.The patient was initially treated with intraperitoneal (ip) vancomycin and ceftazidime (dosages, frequencies, durations not provided).However, the peritoneal effluent cultures returned positive for pasteurella multocida on 26/jan/2024, and the patient¿s ip vancomycin and ceftazidime were discontinued.The patient was transitioned to daily ip augmentin (dosage, duration not provided).The pdrn stated the patient was visiting his son when he contracted the infection.The pdrn attributed causality to multiple cats at the sons¿ residence being present for initiation and termination of ccpd therapy.The patient has been reeducated.The patient has recovered from the serious adverse events and continues to utilize the same cycler.Per the patient¿s pdrn, the reported serious adverse events were unrelated to the patient¿s utilization of any device(s) and/or product(s).

• 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: 18838337
• MDR Text Key: 336961098
• Report Number: 0008030665-2024-00239
• 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,Followup
• Report Date: 03/25/2024

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
• Device Age: MO
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/25/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG