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

Model Number	180111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/23/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty cycler and the patient¿s serious adverse events of cardiac arrest, hospitalization, and subsequent death.The patient reportedly was undergoing ccpd therapy when he experienced a cardiac arrest and was sent to the hospital where he later expired.The patient past medical history and the etiology of the events is unknown; therefore, causality cannot be established.Limited information precluded a more comprehensive investigation.The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Cardiovascular disease (or sudden cardiac death) accounts for the most deaths among the esrd population.Additionally, adults with esrd have mortality rates up to 30-fold higher than the general population.Based on the information available, the liberty cycler cannot be disassociated from the serious adverse events of cardiac arrest and death.While there is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) malfunctioned or failed to meet user expectation.However, due to the lack of information (e.G., esrd death notification, death certificate, discharge summary, treatment data) and no manufacturer evaluation of the suspect device, the patient¿s liberty cycler cannot be excluded from having a possible causal or contributory role in the serious adverse events.Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
On (b)(6) 2022, fresenius became aware this patient experienced a cardiac arrest while undergoing continuous cycling peritoneal dialysis (ccpd) therapy, and later expired at the hospital.Subsequent attempts to obtain additional information (e.G., discharge summary, esrd death notification, autopsy report, treatment data, death certificate) have thus far proven unsuccessful.
Additional Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.Investigation determines that there was no causal relationship between the objective evidence and the alleged event; the alleged event is unconfirmed.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted. .
Event or Problem Description
On 25/oct/2022, fresenius became aware this patient experienced a cardiac arrest while undergoing continuous cycling peritoneal dialysis (ccpd) therapy, and later expired at the hospital.Subsequent attempts to obtain additional information (e.G., discharge summary, esrd death notification, autopsy report, treatment data, death certificate) have thus far proven unsuccessful.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Common Device Name: 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: 15740865
• Report Number: 0002937457-2022-01878
• Device Sequence Number: 15043918
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K123630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 180111
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/05/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; PD SOLUTION.; PD SOLUTION.
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male