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 Problems Chest Pain (1776); Congestive Heart Failure (1783); Dyspnea (1816); Swelling (2091); Weakness (2145); Dizziness (2194)

Event Date 03/20/2020

Event Type  Injury  

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, and the patient¿s hospitalization for dyspnea, swelling, weakness, dizziness, chest pain and chf.Causality is attributed to the patient¿s non-compliance when adhering to the prescribed capd treatment regimen, the patient¿s unspecified difficulty in performing ccpd therapy and an undetected loss of residual renal function for several weeks prior to the hospitalization.Per the pdrn, no harm was attributed to the use of any fresenius product(s) or device(s).Congestive heart failure is one of the most prevalent cardiovascular complications in esrd patients.Additionally, the incidence of chf in the esrd population as compared to the non-esrd population is estimated as being up to 3-fold higher.However, based on the information available, the liberty select cycler cannot be excluded from having a possible contributory role in the events.Due to the lack of treatment records, the specifics regarding the patient¿s unspecified ¿difficulty¿ performing ccpd therapy and the lack of a manufacturer evaluation of the suspect device; there is insufficient evidence to disassociate the liberty select cycler from the event(s).

Event Description

It was reported that a peritoneal dialysis (pd) patient was admitted to the hospital for not being able to complete dialysis for the past 3 days and was experiencing chest pain and shortness of breath.Upon follow up, the medical records confirm the patient¿s hospital admission for dyspnea, swelling, weakness, dizziness, chest pain (reported by pd nurse), congestive heart failure (chf) and three days without rrt.The medical records provided little insight into the details surrounding the patient¿s hospitalization.However, the records indicate the patient received pd therapy on (b)(6) 2020 through (b)(6) 2020 and was awaiting evaluation by vascular surgery for the placement of a tunneled hemodialysis (hd) catheter (not a fresenius product).The patient is scheduled to transition to hd therapy for rrt, per the patient¿s request.Additionally, the patient was diagnosed with acute-on-chronic chf (specifics not provided) and was prescribed ted stockings to improve lower extremity swelling.On (b)(6) 2020, the patient successfully underwent the surgical implantation (confirmed by x-ray) of a tunneled hd catheter (not a fresenius product), with a tentative plan to initiate hd therapy on (b)(6) 2020.On (b)(6) 2020, the patient received her first hd treatment without difficulty and reported an improvement in her dyspnea.While the patient¿s discharge date is unknown, the pd nurse reported the patient was discharged home and is recovering from the events.The patient transitioned to outpatient hd therapy without issue.Per the pdrn, no harm came to the patient due to utilizing any fresenius product(s) or device(s).The pdrn reported prior to the patient¿s hospitalization, the patient was not following the nephrologists¿ orders to increase the continuous ambulatory peritoneal dialysis (capd) prescription (specifics not provided).Therefore, the patient was transitioned to ccpd therapy, but found it too difficult (specifics not provided) and skipped pd therapy for 3 days.Additionally, the pd nurse reported the patient experienced an undetected loss of residual renal function and was under dialyzed (low kt/v) for a ¿few weeks¿ (timeline not provided) prior to hospitalization.

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.

Manufacturer Narrative

Additional information: h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated therapy was initiated and completed on the cycler without complication.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.A go no go check passed.Load cell verification testing was performed with no issues noted.There were no visual discrepancies found during the internal inspection of the returned cycler.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

• 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: 9922503
• MDR Text Key: 186520210
• Report Number: 2937457-2020-00588
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

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: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Device Age: MO
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 04/13/2020; 07/09/2020
• Supplement Dates FDA Received: 04/13/2020; 07/09/2020
• 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: 67 YR
• Patient Weight: 94