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

Model Number 050-87216

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

Patient Problems Abdominal Pain (1685); Fatigue (1849); Peritonitis (2252); Confusion/ Disorientation (2553)

Event Date 06/20/2023

Event Type  Injury  

Event Description

A peritoneal dialysis nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for assistance and during the call the pdrn reported the patient had peritonitis.Upon follow up, the pdrn stated they are familiar with the pd patient who was hospitalized on (b)(6)2023 for altered mental status, unilateral weakness, abdominal pain and cloudy peritoneal effluent fluid.The pdrn affirmed the patient¿s altered mental status and unilateral weakness was attributed to comorbidities that are unrelated to pd therapy or the use of any fresenius product(s), device(s) or drug(s).The pdrn stated peritoneal effluent fluid cultures and a white blood cell (wbc) count obtained in the hospital on (b)(6)2023 presented with acinetobacter baumannii in the culture and a wbc count of 6516/mm3.The pdrn reported the patient was diagnosed with peritonitis due to unknown etiology.The pdrn assumed the patient had a break in aseptic technique during pd therapy at home; however, this could not be confirmed.The pdrn stated, though there was no definitive root cause of this reported infection, there was no indication the patient¿s peritonitis was due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The pdrn reported the patient was able to undergo continuous cyclic pd (ccpd) therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The pdrn stated the patient had an uneventful hospital course and was discharged to home on (b)(6)2023.The pdrn confirmed the patient¿s peritonitis, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The pdrn stated the patient has since transitioned to hemodialysis (hd) for renal replacement therapy on (b)(6)2023 when the patient received a central vascular catheter in an outpatient procedure.The pdrn explained the patient is suspected of membrane failure and pd may not be a viable option for dialysis as the patient will continue hd on an in-center basis.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

Manufacturer Narrative

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 the liberty select cycler with the liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain.It is well established that pd patients are at high risk for infections of the peritoneum.The root cause of this patient¿s adverse event cannot be determined; however, there was no indication the patient¿s peritonitis was due to a deficiency or malfunction of any fresenius product(s) or device(s) as reported by a medical professional.This is further evidenced by the presence of a microorganism that is an opportunistic pathogen that readily transmits to immunocompromised patients such as the esrd population.Therefore, the liberty select cycler with the liberty cycler set can be excluded from the root cause of this patient¿s adverse events.Based on the available information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

A peritoneal dialysis nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for assistance and during the call the pdrn reported the patient had peritonitis.Upon follow up, the pdrn stated they are familiar with the pd patient who was hospitalized on (b)(6) 2023 for altered mental status, unilateral weakness, abdominal pain and cloudy peritoneal effluent fluid.The pdrn affirmed the patient¿s altered mental status and unilateral weakness was attributed to comorbidities that are unrelated to pd therapy or the use of any fresenius product(s), device(s) or drug(s).The pdrn stated peritoneal effluent fluid cultures and a white blood cell (wbc) count obtained in the hospital on (b)(6) 2023 presented with acinetobacter baumannii in the culture and a wbc count of 6516/mm3.The pdrn reported the patient was diagnosed with peritonitis due to unknown etiology.The pdrn assumed the patient had a break in aseptic technique during pd therapy at home; however, this could not be confirmed.The pdrn stated, though there was no definitive root cause of this reported infection, there was no indication the patient¿s peritonitis was due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The pdrn reported the patient was able to undergo continuous cyclic pd (ccpd) therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The pdrn stated the patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.The pdrn confirmed the patient¿s peritonitis, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The pdrn stated the patient has since transitioned to hemodialysis (hd) for renal replacement therapy on (b)(6) 2023 when the patient received a central vascular catheter in an outpatient procedure.The pdrn explained the patient is suspected of membrane failure and pd may not be a viable option for dialysis as the patient will continue hd on an in-center basis.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

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

Correction: h.6.

Event Description

A peritoneal dialysis nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for assistance and during the call the pdrn reported the patient had peritonitis.Upon follow up, the pdrn stated they are familiar with the pd patient who was hospitalized on (b)(6) 2023 for altered mental status, unilateral weakness, abdominal pain and cloudy peritoneal effluent fluid.The pdrn affirmed the patient¿s altered mental status and unilateral weakness was attributed to comorbidities that are unrelated to pd therapy or the use of any fresenius product(s), device(s) or drug(s).The pdrn stated peritoneal effluent fluid cultures and a white blood cell (wbc) count obtained in the hospital on (b)(6) 2023 presented with acinetobacter baumannii in the culture and a wbc count of 6516/mm3.The pdrn reported the patient was diagnosed with peritonitis due to unknown etiology.The pdrn assumed the patient had a break in aseptic technique during pd therapy at home; however, this could not be confirmed.The pdrn stated, though there was no definitive root cause of this reported infection, there was no indication the patient¿s peritonitis was due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The pdrn reported the patient was able to undergo continuous cyclic pd (ccpd) therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The pdrn stated the patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.The pdrn confirmed the patient¿s peritonitis, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The pdrn stated the patient has since transitioned to hemodialysis (hd) for renal replacement therapy on (b)(6) 2023 when the patient received a central vascular catheter in an outpatient procedure.The pdrn explained the patient is suspected of membrane failure and pd may not be a viable option for dialysis as the patient will continue hd on an in-center basis.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

• 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: 17367290
• MDR Text Key: 319473930
• Report Number: 0008030665-2023-00652
• 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: 10/12/2023

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 Model Number: 050-87216
• 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: 07/07/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/16/2023; 10/11/2023
• Supplement Dates FDA Received: 08/16/2023; 10/12/2023
• 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; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 83 KG