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 Stroke/CVA (1770)

Event Date 04/15/2024

Event Type  Injury  

Event Description

On 15/apr/2024 a contact for this male peritoneal dialysis (pd) patient called fresenius technical support for assistance in canceling a treatment on the liberty select cycler.The patient was in the hospital in the intensive care unit (icu).Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment on the liberty select cycler on (b)(6) 2024 when he experienced a stroke.Emergency medical services (ems) were called and responded to the patient¿s home.Ems disconnected the patient from the cycler to transport the patient to the hospital.The patient was admitted to the icu.The patient is not able to communicate.The clinic does not know the type of stroke (ischemic or hemorrhagic).The patient remains hospitalized and has discontinued pd therapy.The pdrn has reviewed the modem data from the patient¿s cycler for the treatment on the date of the event.There were no unusual events prior to the early end of treatment due to the medical emergency.The stroke is not believed to be related to the use of any fresenius device(s) or product(s) and/or their dialysis therapy.The patient has a history of stroke.Additionally, the patient has cardiac issues with bicuspid aortic valve.The patient was recently seeking a third medical opinion from neurology related to recent loss of function/limited function of lower extremities.

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between peritoneal dialysis utilizing the liberty select cycler and the patient event of stroke with hospitalization and discontinuation of pd therapy.However, there is no documentation in the complaint file to show a causal relationship between the adverse event and the liberty select cycler.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.The pdrn stated a review of the patient¿s treatment record did not show any unusual events prior to the patient¿s medical emergency.The patient has a history of stroke as well as bicuspid aortic valve, a congenital heart abnormality that over time tends to become calcified.This can lead to complications which include calcification, aortic stenosis, and thrombus formation leading to stroke.Based on the available information and no allegation or evidence of a malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patient¿s stroke and discontinuation of pd therapy.

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 15/apr/2024 a contact for this male peritoneal dialysis (pd) patient called fresenius technical support for assistance in canceling a treatment on the liberty select cycler.The patient was in the hospital in the intensive care unit (icu).Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in treatment on the liberty select cycler on (b)(6) 2024 when he experienced a stroke.Emergency medical services (ems) were called and responded to the patient¿s home.Ems disconnected the patient from the cycler to transport the patient to the hospital.The patient was admitted to the icu.The patient is not able to communicate.The clinic does not know the type of stroke (ischemic or hemorrhagic).The patient remains hospitalized and has discontinued pd therapy.The pdrn has reviewed the modem data from the patient¿s cycler for the treatment on the date of the event.There were no unusual events prior to the early end of treatment due to the medical emergency.The stroke is not believed to be related to the use of any fresenius device(s) or product(s) and/or their dialysis therapy.The patient has a history of stroke.Additionally, the patient has cardiac issues with bicuspid aortic valve.The patient was recently seeking a third medical opinion from neurology related to recent loss of function/limited function of lower extremities.

• 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: 19160458
• MDR Text Key: 340797349
• Report Number: 0002937457-2024-00666
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2010
• 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
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White