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

Model Number 180343

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

Patient Problem Hypervolemia (2664)

Event Date 03/22/2023

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported to fresenius a pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized due to fluid overload as a result of not completing prescribed pd treatments.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2023 due shortness of breath and fluid overload as a result of not undergoing prescribed pd treatments.It was explained the patient had two consecutive liberty select cyclers that were inoperable.The patient was able to undergo continuous ambulatory pd (capd) with manual solutions at home as an alternative prior to this hospitalization; however, it was stated they underwent these treatments ¿to the best of their ability¿, inferring a deficit in capd technique.Additionally, the patient has comorbidities that elicit fluid overload (exact diagnosis not provided) and the patient¿s noncompliance to pd orders exacerbated their preexisting condition.The patient underwent hemodialysis (hd) for renal replacement therapy through a temporary hd catheter on a hospital provided hd device (brand and model unknown; reported as most likely a ¿t¿ device) for the duration of the admission.No adverse events were reported during this hospitalization and the patient was discharged to home on (b)(6) 2023.The patient continues ccpd therapy on a newly received liberty select cycler at home post-discharge.There was no indication any fresenius device(s) or product(s) directly caused the patient¿s fluid overload, rather it was the non-adherence to pd therapy orders that caused this patient¿s adverse event.This is evidenced by the patient¿s ability to undergo capd in the absence of a cycler but was potentially ineffective in their technique.It was also stated the patient has a preexisting condition that causes fluid overload with no suggestion of pd involvement.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: there was no indication any fresenius device(s) or product(s) directly caused the patient¿s fluid overload, rather it was the non-adherence to pd therapy orders that caused this patient¿s adverse event.This is evidenced by the patient¿s ability to undergo capd in the absence of a cycler but was potentially ineffective in her technique.It was also stated the patient has a preexisting condition that causes fluid overload with no suggestion of pd involvement.Based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

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

A peritoneal dialysis registered nurse [(pd)rn] reported to fresenius a pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized due to fluid overload as a result of not completing prescribed pd treatments.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2023 due shortness of breath and fluid overload as a result of not undergoing prescribed pd treatments.It was explained the patient had two consecutive liberty select cyclers that were inoperable.The patient was able to undergo continuous ambulatory pd (capd) with manual solutions at home as an alternative prior to this hospitalization; however, it was stated they underwent these treatments ¿to the best of their ability¿, inferring a deficit in capd technique.Additionally, the patient has comorbidities that elicit fluid overload (exact diagnosis not provided) and the patient¿s noncompliance to pd orders exacerbated their preexisting condition.The patient underwent hemodialysis (hd) for renal replacement therapy through a temporary hd catheter on a hospital provided hd device (brand and model unknown; reported as most likely a ¿t¿ device) for the duration of the admission.No adverse events were reported during this hospitalization and the patient was discharged to home on (b)(6) 2023.The patient continues ccpd therapy on a newly received liberty select cycler at home post-discharge.There was no indication any fresenius device(s) or product(s) directly caused the patient¿s fluid overload, rather it was the non-adherence to pd therapy orders that caused this patient¿s adverse event.This is evidenced by the patient¿s ability to undergo capd in the absence of a cycler but was potentially ineffective in their technique.It was also stated the patient has a preexisting condition that causes fluid overload with no suggestion of pd involvement.

• 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: 16668063
• MDR Text Key: 312594987
• Report Number: 0002937457-2023-00501
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2013
• 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 SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 90 KG