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

Model Number LIBERTY CYCLER

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

Patient Problems Pneumonia (2011); Hypervolemia (2664)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

Clinical conclusion: there is a temporal relationship between the liberty select cycler and the patient event of fluid volume overload and pneumonia with subsequent hospitalization.However, there is no documentation to show a causal relationship between the event and the liberty select cycler.Additionally, there is no allegation of a machine malfunction or deficiency related to the event.Per the pdrn, this patient has continuous issues with fluid overload and was required to transition to hemodialysis as a result.The etiology of the pneumonia is unknown, but could be a result of the patient¿s inability to control fluid volume.The liberty select cycler has been disassociated from this event as there is no evidence of a machine malfunction or of the machine failing to perform as expected in relation to the event.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

During a technical services call it was reported a peritoneal dialysis patient was hospitalized for four days (admission (b)(6) 2018).During follow up with the peritoneal dialysis registered nurse (pdrn) it was confirmed that the patient was admitted to the hospital for fluid overload and pneumonia.Per the pdrn the patient has continuous issues with fluid overload and that the liberty select cycler was not the cause of her overload.The patient continued pd therapy throughout the hospitalization.Hospital course is unknown, the patient was discharged on (b)(6) 2018.On (b)(6) 2018 the patient was transitioned to hemodialysis due to uncontrolled fluid volume.The patient is currently recovering from the event.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7990283
• MDR Text Key: 124513950
• Report Number: 2937457-2018-03140
• 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: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 10/06/2018
• Initial Date FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2009
• 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 SOLUTION; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 89