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 Uremia (2188); Confusion/ Disorientation (2553)

Event Date 01/07/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship does not exist between ccpd therapy utilizing the liberty select cycler, and the patients serious adverse events of uremia and confusion, as the patient had not utilized the liberty select cycler since approximately (b)(6) 2021.The patient remains hospitalized, and the extent of the patients non-compliance to the prescribed manual pd therapy remains unknown, therefore causality cannot be established.However, the pdrn reported the patients liberty select cycler did not cause or contribute to these serious adverse events.Patient related factors, such as non-compliance, are significant contributing factors limiting the efficacy of a prescribed therapy.Based on the available information, the patients liberty select cycler is disassociated from the events.There is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) or product(s) occurred.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a peritoneal dialysis (pd) patient went to the hospital for not dialyzing and being confused and toxic.Upon follow-up, the patients pd registered nurse (pdrn) reported the patient contacted the pdrn on (b)(6) 2021 regarding drain complications and was instructed to perform manual exchanges every 6 hours.The patient was scheduled for an outpatient surgical revision of the pd catheter on (b)(6) 2021, however the patient never arrived for the appointment.The nephrologist met with the patient on (b)(6) 2020, and it was agreed the patient would transition to hemodialysis (hd), given the recent difficulties with pd therapy.The patient was scheduled to have a permanent hd catheter (not a fresenius product) placed on (b)(6) 2021, however the patient never arrived for the appointment.On (b)(6) 2021, the pdrn was instructed by the nephrologist to call 911 and send an ambulance to the patients residence.The patient was transported and admitted to the hospital for uremia, confusion and missed pd therapy.The patients pd catheter was removed on (b)(6) 2021, and an hd catheter was surgically placed.The patient began undergoing inpatient hd therapy and remains hospitalized as of (b)(6) 2021.The pdrn stated the patients liberty select cycler did not cause or contribute to these events.

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
• MDR Report Key: 11181186
• MDR Text Key: 228430888
• Report Number: 2937457-2021-00086
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 80