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	Insufficient Information (4580)
Date of Event	09/02/2022
Type of Reportable Event	Death
Additional 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 death.Currently, there have been no reported allegations nor is there objective evidence that a liberty select cycler malfunction or product deficiency was associated with the patient¿s death.The exact cause of the patient¿s death remains unknown and cannot be determined with the available information.However, the patient¿s nurse stated the patient had several comorbid conditions and was hospitalized when the death occurred.At the time this clinical investigation was completed, the cycler was not returned to the manufacturer.Regardless due to the death occurring during a pd treatment, the device cannot be completely excluded.
Event or Problem Description
On (b)(6) 2022, a registered nurse (rn) reported that this hospitalized patient expired during dwell 2 of a peritoneal dialysis (pd) treatment with the fresenius cycler.The nurse indicated the patient¿s death was not associated with the performance of the cycler.An additional follow-up call was made to the reporting nurse in attempt to gather more information about the nature of the event.However, the nurse was not able to provide specific patient details.The nurse stated the patent had several unspecified comorbid conditions.The nurse confirmed the patient expired on (b)(6) 2022but reported cause of death as unknown.However, it was stated the cycler was not retuned to manufacturer and the nurse reiterated the death was not related to the performance of the fresenius cycler.No other information was provided or available.
Event or Problem Description
On (b)(6) 2022, a registered nurse (rn) reported that this hospitalized patient expired during dwell 2 of a peritoneal dialysis (pd) treatment with the fresenius cycler.The nurse indicated the patient¿s death was not associated with the performance of the cycler.An additional follow-up call was made to the reporting nurse in attempt to gather more information about the nature of the event.However, the nurse was not able to provide specific patient details.The nurse stated the patent had several unspecified comorbid conditions.The nurse confirmed the patient expired on (b)(6) 2022 but reported cause of death as unknown.However, it was stated the cycler was not retuned to manufacturer and the nurse reiterated the death was not related to the performance of the fresenius cycler.No other information was provided or available.
Additional 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: 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: 15450944
• Report Number: 0002937457-2022-01522
• Device Sequence Number: 5594796
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181108
• 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): 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2011
• 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: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male