MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

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

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

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

Clinical review: 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 (1).The cause of this patient¿s adverse event cannot be determined at the time of this report; 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 presented with no growth, a decrease in symptoms in response to antibiotic therapy provides evidence of a resolving peritonitis infection (2).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 required 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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported experiencing peritonitis.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 abdominal pain.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2024 presented with no growth in the culture and an elevated wbc count (exact count not reported).The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip ceftazidime at 2000 mg (frequency and duration not reported) to address the infection.The patient¿s pd catheter (not a fresenius product) was removed on (b)(6) 2024 during this hospitalization due to the severity of infection.The patient was transitioned to hemodialysis (hd) for renal replacement therapy through an existing arteriovenous access on a hospital provided hd machine (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was confirmed, though the exact source of 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 recovered from this event as remains asymptomatic on antibiotic therapy.The patient continues hd therapy on an in-center basis with a plan to return to pd therapy on the same liberty select cycler once cleared by his physician.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported experiencing peritonitis.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 abdominal pain.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2024 presented with no growth in the culture and an elevated wbc count (exact count not reported).The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip ceftazidime at 2000 mg (frequency and duration not reported) to address the infection.The patient¿s pd catheter (not a fresenius product) was removed on (b)(6) 2024 during this hospitalization due to the severity of infection.The patient was transitioned to hemodialysis (hd) for renal replacement therapy through an existing arteriovenous access on a hospital provided hd machine (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was confirmed, though the exact source of 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 recovered from this event as remains asymptomatic on antibiotic therapy.The patient continues hd therapy on an in-center basis with a plan to return to pd therapy on the same liberty select cycler once cleared by his physician.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18966488
• MDR Text Key: 338434386
• Report Number: 0002937457-2024-00496
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG