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 05/23/2021

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 exist between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse event(s) of fluid overload, characterized by dyspnea and hypervolemia, which required hospitalization.Causality was attributed (by the nephrologist) to the patient experiencing multiple drain complications and unspecified cycler alarms, preventing the patient from attaining adequate therapy.Fluid overload is a common and often preventable process.Factors such as, non-compliance, pd prescription, mechanical/device failure, medication, fluid/dietary restrictions can all be significant contributing factors limiting the efficacy of the modality.Based on the totality of the information available, the liberty select cycler cannot be excluded from having a possible causal/contributory role in the patient¿s fluid overload.There is no objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused/contributed to the events.If the cycler is returned, a manufacturer evaluation may dissociate the liberty select cycler from having contributed to the serious adverse events.However, without a discharge summary, treatment records, and/or definitive causality, this clinical investigation cannot disassociate the device from the serious adverse events.

Event Description

It was reported that a peritoneal dialysis patient was hospitalized on (b)(6) 2021.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient presented (mid-day) to the emergency room on (b)(6) 2021 due to shortness of breath (dyspnea).Radiological studies indicated the patient was hypervolemic, and the patient was formally admitted for fluid overload.The patient¿s pd catheter (not a fresenius product) was evaluated and found to be in proper position and functioning appropriately.Additionally, the pdrn reported the patient has continued to undergo continuous cycling peritoneal dialysis (ccpd) while hospitalized without issue utilizing a baxter cycler.The pdrn stated the nephrologist feels the liberty select cycler is the root cause of the patient¿s fluid overload.The patient has reportedly been experiencing multiple drain complications and unspecified cycler alarms which are ¿preventing the patient from receiving adequate therapy.¿ the patient¿s cycler was replaced based on the medical professional¿s allegation.The patient was discharged home on (b)(6) 2021 and has begun utilizing the replacement liberty select cycler without reported issue.The patient is recovering from the events.The discharge summary was requested; however, the document has not been received by the clinic.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer.No physical damage was noted during an external visual inspection.There was dried fluid within the cassette compartment.There were no particulates, burrs or sharp edges in the cassette area that could have punctured the cassette membrane.An as-received simulated treatment was initiated and completed without failures.The cycler underwent and passed a system air leak test, valve actuation test, and a patient pressure sensor calibration check.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal visual inspection of the cycler found dried fluid on the bottom cover under the pump assembly and behind mushroom heads a & b.The cause of the observed dried fluid could not be determined.There were no other visual discrepancies observed during the internal inspection.A review of the device manufacturing records was conducted and 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, no malfunctions were found that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.The cycler was refurbished following the evaluation.

Event Description

It was reported that a peritoneal dialysis patient was hospitalized on (b)(6) 2021.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient presented (mid-day) to the emergency room on (b)(6) 2021 due to shortness of breath (dyspnea).Radiological studies indicated the patient was hypervolemic, and the patient was formally admitted for fluid overload.The patient¿s pd catheter (not a fresenius product) was evaluated and found to be in proper position and functioning appropriately.Additionally, the pdrn reported the patient has continued to undergo continuous cycling peritoneal dialysis (ccpd) while hospitalized without issue utilizing a baxter cycler.The pdrn stated the nephrologist feels the liberty select cycler is the root cause of the patient¿s fluid overload.The patient has reportedly been experiencing multiple drain complications and unspecified cycler alarms which are ¿preventing the patient from receiving adequate therapy.¿ the patient¿s cycler was replaced based on the medical professional¿s allegation.The patient was discharged home on (b)(6) 2021 and has begun utilizing the replacement liberty select cycler without reported issue.The patient is recovering from the events.The discharge summary was requested; however, the document has not been received by the clinic.

• 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: 11985197
• MDR Text Key: 255924621
• Report Number: 2937457-2021-01231
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Device Age: MO
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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: 65 YR
• Patient Weight: 88