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

Catalog Number RTLR180343

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

Patient Problem Hypervolemia (2664)

Event Date 01/15/2024

Event Type  Injury  

Event Description

A nurse reported that a peritoneal dialysis (pd) patient was admitted to the hospital on (b)(6) 2024 for fluid volume overload.Additionally, it was reported that the patient had been in the hospital for approximately two months (dates not provided) prior to this current hospitalization.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was hospitalized on (b)(6)2024 for fluid volume overload (fvo).The patient had been experiencing slow drains during pd treatments on the liberty select cycler.The patient had been instructed to contact fresenius technical support for assistance in troubleshooting.Furthermore, the patient was instructed to supplement with manual treatments until the issues resolved.The pdrn stated the patient did not follow the instructions which led to the hospitalization for fvo.The patient was discharged on (b)(6) 2024.The pdrn stated that there was no malfunction or issue with the cycler that caused the fvo.It was the failure of the patient to follow the pdrn¿s instructions which led to the fvo.The patient received a new cycler and has not reported any issues.The prior hospitalization which was mentioned was not related to pd therapy or use of any fresenius product(s).A review of the patient¿s treatment records indicated that on 09/jan/2024 during cycle 4 of 5 of the treatment, there was a power failure after 184 minutes of drain time.It is unknown if the patient turned the cycler off or if there was an issue which powered the machine off.The treatment net ultrafiltration (uf) was -344ml.Subsequently on 10/jan/2024 during cycle 1 of treatment, there was another power failure noted after 664 minutes of drain time.Again, it is unknown if the patient turned the machine off.The net uf was -837ml.The treatment records from 08/jan/2024 did not show any issues with extensive slow drains and the patient did not have a net negative uf.There is no information indicating if the patient completed any treatments on the liberty select cycler from (b)(6) 2024, when the patient was admitted to the hospital.No further information was provided.

Manufacturer Narrative

Clinical review: there is a temporal relationship between peritoneal dialysis therapy utilizing the liberty select cycler and the patient event of fluid volume overload with hospitalization.There is no documentation in the complaint file to show a causal relationship between the patient event and use of the liberty select cycler.There is no allegation of a device malfunction reported for this event.The patient reported slow drains which were indicated on two treatments.The patient had been instructed to contact technical support earlier than the call that was made on 11/jan/2024.The patient was instructed to complete manual exchanges to supplement cycler treatments until the slow drain issue was resolved.The pdrn stated the patient did not follow the instructions which led to the fvo.There is no documentation that any clinical assessment was completed on the patient to check for pd catheter issues, positional issues, or anatomical problems that could be causing the patient¿s slow drains.No information was provided as to the cause of the slow drains which resulted in the fvo.Fluid overload in pd patients may reflect any combination of inappropriate prescription, noncompliance, loss of residual renal function, mechanical problems, and peritoneal membrane dysfunction.Based on information, the cycler can be excluded as the cause of the fluid overload with hospitalization.Plant investigation: no parts were returned.A review was performed.An investigation of the device manufacturer.Records was conducted.There were no non-conformances, or any associated rework identified during the manufacturing process.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 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18626089
• MDR Text Key: 334369705
• Report Number: 0002937457-2024-00188
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female