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 04/16/2021

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 exists between ccpd therapy utilizing the liberty select cycler, and the patients serious adverse event of fluid overload (characterized by dyspnea and fatigue during exertion/walking), mild diarrhea, chills and myalgias, which warranted hospitalization.The patient and hospital doctor both allege the patients liberty select cycler was malfunctioning and not completing pd therapy correctly.Fluid overload is a common finding among dialysis patients and is frequently multifactorial in its etiology.Based on the totality of the information available, the liberty select cycler cannot be excluded from having a possible causal and/or contributory role in the serious adverse events experienced by the patient.There is currently no objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused and/or contributed to the serious adverse events.However, the patient was unable to utilize his liberty select cycler for 72 hours prior to hospitalization.If the liberty select cycler is returned, a manufacturer evaluation may dissociate the cycler from having caused and/or contributed to the serious adverse events.However, without definitive causality being established, this clinical investigation cannot disassociate the device from the serious adverse events.

Event Description

It was reported a patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on (b)(6) 2021 (initially reported as (b)(6) 2021) for fluid overload.Upon follow up with the patients user facility, medical records were received on (b)(6) 2021.The documents state the patient was hospitalized for fluid overload, likely secondary to a malfunctioning peritoneal dialysis machine at home.The patient presented to the emergency room (er) with complaints of dyspnea, fatigue during exertion/walking, mild diarrhea, chills and myalgias, worsening over the past 72 hours.The patient was subsequently admitted for ultrafiltration, utilizing manual exchanges with baxter solutions.The patient achieved good ultrafiltration ((b)(6) 2021 = 1800 ml, (b)(6) 2021 = 1700 ml, and (b)(6) 2021 = 1000 ml), and his symptoms subsided.The patient was discharged home on (b)(6) 2021 in stable condition.The patient has recovered from the events and continues to undergo ccpd therapy utilizing the replacement liberty select cycler without reported issue.

Event Description

It was reported a patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on (b)(6) 2021 (initially reported as 15/apr/2021) for fluid overload.Upon follow up with the patient¿s user facility, medical records were received on (b)(6) 2021.The documents state the patient was hospitalized for fluid overload, ¿likely secondary to a malfunctioning peritoneal dialysis machine at home.¿ the patient presented to the emergency room (er) with complaints of dyspnea, fatigue during exertion/walking, mild diarrhea, chills and myalgias, worsening over the past 72 hours.The patient was subsequently admitted for ultrafiltration, utilizing manual exchanges with baxter solutions.The patient achieved good ultrafiltration ((b)(6) 2021 = 1800 ml, 17/apr/2021 = 1700 ml, and (b)(6) 2021 = 1000 ml), and his symptoms subsided.The patient was discharged home on 18/apr/2021 in stable condition.The patient has recovered from the events and continues to undergo ccpd therapy utilizing the replacement liberty select cycler without reported issue.

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: 11784763
• MDR Text Key: 258969002
• Report Number: 2937457-2021-00994
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 05/20/2021
• 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: 60 YR
• Patient Weight: 111