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); Fever (1858); Peritonitis (2252)

Event Date 03/28/2024

Event Type  Injury  

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 with liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain and fever.It is well established that pd patients are at high risk for infections of the peritoneum.The cause of this infection remains unknown; however, there was no indication the patient¿s peritonitis, and the associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s) as reported by a medical professional.Though effluent fluid cultures were not reported, a decrease in symptoms in response to antibiotic therapy provides evidence of a resolving peritonitis infection.Therefore, the liberty select cycler with the liberty cycler set can be excluded as a root cause or contributor to this patient¿s adverse event.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

On (b)(6) 2024, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported to fresenius technical services they needed to discontinue a pd treatment to go to the hospital for a fever.There was no specific allegation this adverse event was related to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2024 following fever, abdominal pain and cloudy peritoneal effluent fluid.It was explained laboratory testing was conducted in the hospital but not reported to the outpatient clinic as the patient was still awaiting discharge to home.The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intravenous levofloxacin at 500 mg daily to address this infection while hospitalized.The patient has been able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient is recovering from this event while awaiting discharge home.It was confirmed, though the exact cause of this infection remains unknown, there was no indication the patient¿s peritonitis, and the associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue ccpd therapy on the same liberty select cycler at home upon discharge.

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 28/mar/2024, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported to fresenius technical services they needed to discontinue a pd treatment to go to the hospital for a fever.There was no specific allegation this adverse event was related to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2024 following fever, abdominal pain and cloudy peritoneal effluent fluid.It was explained laboratory testing was conducted in the hospital but not reported to the outpatient clinic as the patient was still awaiting discharge to home.The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intravenous levofloxacin at 500 mg daily to address this infection while hospitalized.The patient has been able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient is recovering from this event while awaiting discharge home.It was confirmed, though the exact cause of this infection remains unknown, there was no indication the patient¿s peritonitis, and the associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue ccpd therapy on the same liberty select cycler at home upon discharge.

• 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: 19066883
• MDR Text Key: 339671690
• Report Number: 0008030665-2024-00336
• 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: 04/26/2024

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: 03/28/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/26/2024
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG