MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 050-87212

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

Patient Problems Abdominal Pain (1685); Peritonitis (2252); Malaise (2359)

Event Date 01/08/2023

Event Type  Injury  

Manufacturer Narrative

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 with hospitalization.However, there is no documentation in the complaint file to show a causal relationship between the adverse event and use of the cycler with cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for this event.The culture results were positive for two organisms, corynebacterium jeikeium and micrococcus luteus.C.Jeikeium is an organism which is part of the normal cutaneous flora and m.Luteus colonizes the human skin, mucosa, and mouth.This is indicative of a breach in aseptic technique during treatment.In addition, the pdrn stated that this patient does what she wants when it comes to pd therapy.Although no information was provided related to the determined cause of the peritonitis, all pd patients are at risk of peritonitis due to a compromised immune system and the increase of potential for microbial contamination from dialysis techniques.Most cases of peritonitis are caused by touch contamination by the patient with the pd catheter being a source of entry for organisms into the peritoneum.Based on the limited 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 reported peritonitis event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient report having peritonitis.Additional information was obtained through follow-up with the peritoneal dialysis registered nurse (pdrn).The patient contacted the on-call pdrn on (b)(6) 2023 with complaints of not feeling well and abdominal pain.The patient was instructed to take a one-time prophylactic dose of antibiotics (drug, route, and dosage not provided).The patient was not improving and decided to go to the emergency room (er) later that day.The patient was admitted to the hospital with a diagnosis of peritonitis.The patient was initiated on antibiotic therapy (no information was available).The pd effluent cultures resulted positive for two organisms: corynebacterium jeikeium and micrococcus luteus.During the hospitalization, the patient went into a hypertensive emergency unrelated to dialysis or the peritonitis event.This extended the hospitalization.The patient was discharged from the hospital on (b)(6) 2023.Upon discharge, the patient¿s antibiotic regimen was intraperitoneal (ip) vancomycin for 21 days (dose and frequency unknown).The patient continues to complete pd therapy utilizing the liberty select cycler during recovery.The cause of the patient¿s peritonitis event was not identified.The pdrn stated that a home visit was performed and nothing specific was found that identified the source of the peritonitis.The pdrn did state this patient does what she wants when it comes to pd treatments, so that a breach in aseptic technique cannot be ruled out.

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 report having peritonitis.Additional information was obtained through follow-up with the peritoneal dialysis registered nurse (pdrn).The patient contacted the on-call pdrn on 08/jan/2023 with complaints of not feeling well and abdominal pain.The patient was instructed to take a one-time prophylactic dose of antibiotics (drug, route, and dosage not provided).The patient was not improving and decided to go to the emergency room (er) later that day.The patient was admitted to the hospital with a diagnosis of peritonitis.The patient was initiated on antibiotic therapy (no information was available).The pd effluent cultures resulted positive for two organisms: corynebacterium jeikeium and micrococcus luteus.During the hospitalization, the patient went into a hypertensive emergency unrelated to dialysis or the peritonitis event.This extended the hospitalization.The patient was discharged from the hospital on 15/jan/2023.Upon discharge, the patient¿s antibiotic regimen was intraperitoneal (ip) vancomycin for 21 days (dose and frequency unknown).The patient continues to complete pd therapy utilizing the liberty select cycler during recovery.The cause of the patient¿s peritonitis event was not identified.The pdrn stated that a home visit was performed and nothing specific was found that identified the source of the peritonitis.The pdrn did state this patient does what she wants when it comes to pd treatments, so that a breach in aseptic technique cannot be ruled out.

Manufacturer Narrative

Correction: g.3.Date should be 4-5-2023 for mfr report #: 8030665-2023-00161 follow up report #2.

Event Description

A peritoneal dialysis (pd) patient report having peritonitis.Additional information was obtained through follow-up with the peritoneal dialysis registered nurse (pdrn).The patient contacted the on-call pdrn on (b)(6) 2023 with complaints of not feeling well and abdominal pain.The patient was instructed to take a one-time prophylactic dose of antibiotics (drug, route, and dosage not provided).The patient was not improving and decided to go to the emergency room (er) later that day.The patient was admitted to the hospital with a diagnosis of peritonitis.The patient was initiated on antibiotic therapy (no information was available).The pd effluent cultures resulted positive for two organisms: corynebacterium jeikeium and micrococcus luteus.During the hospitalization, the patient went into a hypertensive emergency unrelated to dialysis or the peritonitis event.This extended the hospitalization.The patient was discharged from the hospital on (b)(6) 2023.Upon discharge, the patient¿s antibiotic regimen was intraperitoneal (ip) vancomycin for 21 days (dose and frequency unknown).The patient continues to complete pd therapy utilizing the liberty select cycler during recovery.The cause of the patient¿s peritonitis event was not identified.The pdrn stated that a home visit was performed and nothing specific was found that identified the source of the peritonitis.The pdrn did state this patient does what she wants when it comes to pd treatments, so that a breach in aseptic technique cannot be ruled out.

Manufacturer Narrative

Correction: h.6.

Event Description

A peritoneal dialysis (pd) patient report having peritonitis.Additional information was obtained through follow-up with the peritoneal dialysis registered nurse (pdrn).The patient contacted the on-call pdrn on (b)(6) 2023 with complaints of not feeling well and abdominal pain.The patient was instructed to take a one-time prophylactic dose of antibiotics (drug, route, and dosage not provided).The patient was not improving and decided to go to the emergency room (er) later that day.The patient was admitted to the hospital with a diagnosis of peritonitis.The patient was initiated on antibiotic therapy (no information was available).The pd effluent cultures resulted positive for two organisms: corynebacterium jeikeium and micrococcus luteus.During the hospitalization, the patient went into a hypertensive emergency unrelated to dialysis or the peritonitis event.This extended the hospitalization.The patient was discharged from the hospital on (b)(6) 2023.Upon discharge, the patient¿s antibiotic regimen was intraperitoneal (ip) vancomycin for 21 days (dose and frequency unknown).The patient continues to complete pd therapy utilizing the liberty select cycler during recovery.The cause of the patient¿s peritonitis event was not identified.The pdrn stated that a home visit was performed and nothing specific was found that identified the source of the peritonitis.The pdrn did state this patient does what she wants when it comes to pd treatments, so that a breach in aseptic technique cannot be ruled out.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 16380468
• MDR Text Key: 309594371
• Report Number: 0008030665-2023-00161
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• 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,Followup,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87212
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/07/2023
• 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; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female