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 Problems Dyspnea (1816); Hypervolemia (2664)

Event Date 03/16/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, it was reported that this patient on peritoneal dialysis (pd) was hospitalized for fluid volume overload due to fresenius cycler not draining properly.The patient¿s pd nurse indicated that on (b)(6) 2024, the patient was experiencing patient line is blocked and drain complication messages during pd treatment on the fresenius cycler.It was reported that the patient was not able to complete pd treatment on the cycler due to the reported alarms.However, it was reported that the patient completed treatment manually.Subsequently, the patient was hospitalized on (b)(6) 2024 for fluid volume overload characterized by shortness of breath.The patient received both hemodialysis and pd therapy (using a hospital cycler; details not provided) during the hospitalization.On (b)(6) 2024, the patient was discharged home continuing pd therapy manually.Initially, it was reported that it was unknown what may have caused the machine issue and that it may have been due to operator error and the patient may need re-training.However, it was also indicated that due to reported machine alarms the cycler was replaced.Per the nurse, the patient began using the new cycler for pd therapy on (b)(6) 2025 without any reported issues.The patient is recovering from the event.

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 pd therapy with the liberty select cycler and the patient¿s subsequent hospitalization for fluid volume overload.Fluid volume overload is a common complication in patients with end stage renal disease (esrd) on dialysis.Based on all the available information, the fresenius cycler cannot be excluded as a possible factor in the patient¿s fluid volume overload event.The patient was reportedly experiencing drain issues with the fresenius cycler the day before hospitalization resulting in the patient completing the pd treatment manually.The fresenius cycler was replaced and currently it is unknown what may have caused the reported drain issue as manufacturer product investigation is pending at the time this clinical investigation was completed.Should additional information become available, please resubmit for a clinical review and this clinical investigation will be updated accordingly.

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.

Event Description

On 19/mar2024, it was reported that this patient on peritoneal dialysis (pd) was hospitalized for fluid volume overload due to fresenius cycler not draining properly.The patient¿s pd nurse indicated that on (b)(6) 2024, the patient was experiencing patient line is blocked and drain complication messages during pd treatment on the fresenius cycler.It was reported that the patient was not able to complete pd treatment on the cycler due to the reported alarms.However, it was reported that the patient completed treatment manually.Subsequently, the patient was hospitalized on (b)(6) 2024 for fluid volume overload characterized by shortness of breath.The patient received both hemodialysis and pd therapy (using a hospital cycler; details not provided) during the hospitalization.On (b)(6) 2024, the patient was discharged home continuing pd therapy manually.Initially, it was reported that it was unknown what may have caused the machine issue and that it may have been due to operator error and the patient may need re-training.However, it was also indicated that due to reported machine alarms the cycler was replaced.Per the nurse, the patient began using the new cycler for pd therapy on (b)(6) 2025 without any reported issues.The patient is recovering from the event.

• 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: 18993774
• MDR Text Key: 338886350
• Report Number: 0002937457-2024-00533
• 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: K222318
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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
• Device Age: MO
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• 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: 72 YR
• Patient Sex: Male