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 Problems Uremia (2188); Electrolyte Imbalance (2196)

Event Date 05/20/2023

Event Type  Injury  

Event Description

During follow-up for an iq drive not detected message, it was reported that this peritoneal dialysis (pd) patient was hospitalized on (b)(6) 2023 for low sodium and potassium.The patient was experiencing delirium due to transitioning from hemodialysis (hd) to pd on (b)(6) 2023.It was reported that the patient completed pd treatment at the clinic on the (b)(6).The patient then performed pd at home on the (b)(6) for the first time.It was also reported by the patient contact that the nephrologist believed the patient¿s hospitalization was related to the pd therapy as hd had worked in the past.Additional information was provided by the patient¿s peritoneal dialysis registered nurse (pdrn).The patient went to the hospital on (b)(6) 2023 with confusion and weakness.The patient was uremic and admitted with hyperkalemia and hyponatremia.It was determined that the patient had peritoneal dialysis failure.The failure was not related to use of the liberty select cycler or other fresenius product(s).The patient was not able to continue with pd due to the failure and was permanently transitioned back to hd on (b)(6) 2023.It could not be confirmed if the patient remained hospitalized.It is expected that the patient will be discharged to a rehabilitation facility upon discharge from the hospital.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. clinical review: there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

Event Description

During follow-up for an iq drive not detected message, it was reported that this peritoneal dialysis (pd) patient was hospitalized on (b)(6) 2023 for low sodium and potassium.The patient was experiencing delirium due to transitioning from hemodialysis (hd) to pd on (b)(6) 2023.It was reported that the patient completed pd treatment at the clinic on the (b)(6).The patient then performed pd at home on the 19th for the first time.It was also reported by the patient contact that the nephrologist believed the patient¿s hospitalization was related to the pd therapy as hd had worked in the past.Additional information was provided by the patient¿s peritoneal dialysis registered nurse (pdrn).The patient went to the hospital on (b)(6) 2023 with confusion and weakness.The patient was uremic and admitted with hyperkalemia and hyponatremia.It was determined that the patient had peritoneal dialysis failure.The failure was not related to use of the liberty select cycler or other fresenius product(s).The patient was not able to continue with pd due to the failure and was permanently transitioned back to hd on (b)(6) 2023.It could not be confirmed if the patient remained hospitalized.It is expected that the patient will be discharged to a rehabilitation facility upon discharge from the hospital.

Manufacturer Narrative

Corrected information provided in a2 and h6.

Event Description

During follow-up for an iq drive not detected message, it was reported that this peritoneal dialysis (pd) patient was hospitalized on (b)(6) 2023 for low sodium and potassium.The patient was experiencing delirium due to transitioning from hemodialysis (hd) to pd on (b)(6) 2023.It was reported that the patient completed pd treatment at the clinic on the (b)(6).The patient then performed pd at home on the (b)(6)for the first time.It was also reported by the patient contact that the nephrologist believed the patient¿s hospitalization was related to the pd therapy as hd had worked in the past.Additional information was provided by the patient¿s peritoneal dialysis registered nurse (pdrn).The patient went to the hospital on (b)(6) 2023 with confusion and weakness.The patient was uremic and admitted with hyperkalemia and hyponatremia.It was determined that the patient had peritoneal dialysis failure.The failure was not related to use of the liberty select cycler or other fresenius product(s).The patient was not able to continue with pd due to the failure and was permanently transitioned back to hd on (b)(6) 2023.It could not be confirmed if the patient remained hospitalized.It is expected that the patient will be discharged to a rehabilitation facility upon discharge from the hospital.

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: 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: 17060230
• MDR Text Key: 316516683
• Report Number: 0002937457-2023-00797
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• 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
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2010
• 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
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male