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 Problems Low Blood Pressure/ Hypotension (1914); Hypervolemia (2664)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing a cycler reported being hospitalized for low blood pressure and low potassium due to dialysis draining too much fluid from her.There was no specific allegation this event was related to a deficiency or malfunction of any device(s) or product(s) in the initial reporting.Upon follow up with the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2024 following hypotension and hypokalemia.It was explained the patient¿s hypotension and hypokalemia were attributed to a combination of non-compliance to cardiac medications and her existing pd prescription pulling off too much fluid.The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.The patient¿s pd prescription was reevaluated by the outpatient clinic physician following her discharge to shorter dwell times and decreased fill volumes.It was confirmed the patient¿s hypotension, hypokalemia and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s), rather this event was due to an inappropriate pd prescription for this patient¿s physiology.The patient recovered from this event and continues ccpd therapy on the same liberty select cycler at home post-discharge.

• 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: 18937431
• MDR Text Key: 338075267
• Report Number: 0002937457-2024-00474
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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.; LIBERTY CYCLER SET.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 55 KG