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

Model Number 180343

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

Patient Problem Uremia (2188)

Event Date 10/09/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between pd therapy with the liberty select cycler and the patient¿s hospitalization for uremia among other concomitant medical issues related to dialysis.The patient was reportedly experiencing a patient line is blocked soft alarm and drain complications while using the fresenius cycler for approximately one week prior to this hospitalization despite using heparin (an anticoagulant) for fibrin, per standing orders.Manufacturer product analysis of the cycler is ending at the time this clinical investigation was completed.Therefore, it cannot be determined whether or not the cycler was having any performance issues.Uremia is not uncommon in patients with end stage renal disease.Dialysis treatments can help patient uremia through the diffusion of urea out of the patient¿s body during dialysis.In peritoneal dialysis (pd), manual exchanges are very often used to supplement pd treatment if a patient can not complete pd treatment on the cycler.Missed dialysis treatments are a well-known risk factor for hospitalization.The patient¿s nurse reported the patient was instructed but did not adhere to performing manual pd to complete the dialysis treatment.While the fresenius cycler cannot be excluded as a contributory factor; the patient¿s non-adherence is a likely factor in the patient¿s inadequate dialysis and uremia.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported to fresenius technical support by the peritoneal dialysis (pd) patient that they were hospitalized and very sick.The patient initially contacted fresenius for a patient line is blocked soft alarm that had occurred with the liberty select cycler for approximately one week.Pd data was captured and reviewed for dates (b)(6) 2021.It has been noted that on drain 3 of pd treatment for (b)(6) 2021 that the patient drained 4365 which was 190% of the fill volume of 2295.However, upon further review the patient had two previous cycles that resulted in a total of 1129 for that treatment, suggesting the large drain volume was due to a cumulation of fluid to be removed.Regardless, the cycler was processed for replacement due to the large drain volume.No patient injuries were recorded during this call.In additional follow-up, the patient¿s pd nurse confirmed that the patient was intermittently experiencing drain complications with the cycler the week prior to hospitalization (on (b)(6) 2021).The nurse reported the patient was experiencing fibrin and was using heparin, per standing orders.Reportedly, despite medicating with heparin the patient continued to experience the drain issues.The nurse confirmed the patient did not have any adverse effects on treatment dates (b)(6) 2021.Per the nurse, the patient was instructed to do a stat drain and then perform manual pd exchanges when experiencing drain issues with the cycler.Subsequently, on (b)(6) 2021, the patient was hospitalized for multiple medical issues including uremia, gallbladder disease, covid and unspecified cancer related illness.The patient is receiving pd treatments with a baxter cycler in the hospital without any reported issues with draining or filling (the hospital only uses baxter products).The patient remained hospitalized at the time follow-up was completed.No further information about the hospitalization is available.The nurse indicated the patient was quite ill due to the other concomitant medial issues unrelated to dialysis.In terms of causality for the uremia, the nurse stated the patient was not adherent with performing manual pd exchanges that were required to complete pd treatment.The nurse stated the uremia was related to inadequate dialysis from ongoing drain issues with the cycler combined with the patient¿s non-compliance to manual pd therapy.

Event Description

It was reported to fresenius technical support by the peritoneal dialysis (pd) patient that they were hospitalized and very sick.The patient initially contacted fresenius for a patient line is blocked soft alarm that had occurred with the liberty select cycler for approximately one week.Pd data was captured and reviewed for dates (b)(6) 2021.It has been noted that on drain 3 of pd treatment for (b)(6) 2021 that the patient drained 4365 which was 190% of the fill volume of 2295.However, upon further review the patient had two previous cycles that resulted in a total of 1129 for that treatment, suggesting the large drain volume was due to a cumulation of fluid to be removed.Regardless, the cycler was processed for replacement due to the large drain volume.No patient injuries were recorded during this call.In additional follow-up, the patient¿s pd nurse confirmed that the patient was intermittently experiencing drain complications with the cycler the week prior to hospitalization (on (b)(6) 2021).The nurse reported the patient was experiencing fibrin and was using heparin, per standing orders.Reportedly, despite medicating with heparin the patient continued to experience the drain issues.The nurse confirmed the patient did not have any adverse effects on treatment dates (b)(6) 2021.Per the nurse, the patient was instructed to do a stat drain and then perform manual pd exchanges when experiencing drain issues with the cycler.Subsequently, on (b)(6) 2021, the patient was hospitalized for multiple medical issues including uremia, gallbladder disease, covid and unspecified cancer related illness.The patient is receiving pd treatments with a baxter cycler in the hospital without any reported issues with draining or filling (the hospital only uses baxter products).The patient remained hospitalized at the time follow-up was completed.No further information about the hospitalization is available.The nurse indicated the patient was quite ill due to the other concomitant medial issues unrelated to dialysis.In terms of causality for the uremia, the nurse stated the patient was not adherent with performing manual pd exchanges that were required to complete pd treatment.The nurse stated the uremia was related to inadequate dialysis from ongoing drain issues with the cycler combined with the patient¿s non-compliance to manual pd therapy.

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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12727813
• MDR Text Key: 279276086
• Report Number: 2937457-2021-02194
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2010
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male