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 Dyspnea (1816); Hypervolemia (2664)

Event Date 10/06/2022

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, and the patient¿s serious adverse events of fluid overload, characterized by dyspnea, which warranted hospitalization.The patient/pdrn allege the patient¿s liberty select cycler was malfunctioning and not performing pd therapy correctly.Fluid overload is a common finding among dialysis patients and is frequently multifactorial in its etiology.Based on the limited information available, the liberty select cycler cannot be excluded from having a possible causal or contributory role in the serious adverse events.Presently, there is no physical/objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused or contributed to the event(s).However, given the pdrns allegation, no discharge summary, no treatment data, and no manufacturer evaluation of the suspect device; there is insufficient evidence to exclude the liberty select cycler from having caused or contributed to the serious adverse events.

Event Description

On (b)(6) 2022, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on (b)(6) 2022, after not performing ccpd therapy since (b)(6) 2022.No additional information provided during intake.During follow-up, the patient¿s primary pdrn confirmed the patient presented to the emergency room (er) on (b)(6) 2022 with shortness of breath (dyspnea).The pdrn reported the patient underwent several x-rays, which determined the patient was fluid overloaded.The patient was admitted and was treated with ccpd therapy utilizing a hospital cycler (manufacturer unknown) and 4.25% dextrose-based dialysate to promote greater fluid removal (ultrafiltration).The pdrn reported the patient¿s dyspnea improved (still recovering) and was discharged home on (b)(6) 2022.The pdrn attributed causality to the patient¿s malfunctioning liberty select cycler.The pdrn reported the patient experienced alarms which prevented her from performing ccpd therapy for 72 hours prior to admission.The patient did have access to the correct supplies to perform continuous ambulatory pd (capd) but elected to not perform manual exchanges (rationale not provided).Following discharge, the patient resumed ccpd therapy at home utilizing the replacement liberty select cycler without reported issue.

Manufacturer Narrative

Additional information provided in d9 and h3.Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.There was no evidence of dried fluid present within the cassette compartment.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.There were no visual indications of particulates within the cassette area.An (as received) simulated treatment was performed and completed.The cycler weighed fill volume values were within tolerance for the cycler.The cycler underwent and passed a system air leak test and valve actuation test.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal inspection of the cycler showed that there were visual indications of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the encountered dried fluid could not be determined.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.

Event Description

On 11/oct/2022, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on 6/oct/2022, after not performing ccpd therapy since 3/oct/2022.No additional information provided during intake.During follow-up, the patient¿s primary pdrn confirmed the patient presented to the emergency room (er) on 6/oct/2022 with shortness of breath (dyspnea).The pdrn reported the patient underwent several x-rays, which determined the patient was fluid overloaded.The patient was admitted and was treated with ccpd therapy utilizing a hospital cycler (manufacturer unknown) and 4.25% dextrose-based dialysate to promote greater fluid removal (ultrafiltration).The pdrn reported the patient¿s dyspnea improved (still recovering) and was discharged home on 12/oct/2022.The pdrn attributed causality to the patient¿s malfunctioning liberty select cycler.The pdrn reported the patient experienced alarms which prevented her from performing ccpd therapy for 72 hours prior to admission.The patient did have access to the correct supplies to perform continuous ambulatory pd (capd) but elected to not perform manual exchanges (rationale not provided).Following discharge, the patient resumed ccpd therapy at home utilizing the replacement liberty select cycler without reported issue.

• 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: 15633744
• MDR Text Key: 302020999
• Report Number: 0002937457-2022-01748
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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
• Device Age: MO
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female