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

Model Number LIBERTY SELECT CYCLER

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

Patient Problems Pneumonia (2011); Swelling (2091); Hypervolemia (2664)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s adverse event(s) of fluid overload and possible pneumonia which warranted hospitalization.However, during follow-up it could not be determined if the patient was actively being treated for pneumonia, therefore its etiology and/or causal factors could not be established.Additionally it is well documented patients with ckd are at a higher risk for contracting pneumonia than the general population; due to an overall increased risk for infection.The pdrn reported the event of fluid overload was due to the patient¿s non-compliance and ¿skipping¿ pd treatments.Non-adherence to pd therapy is a major concern when determining its efficacy (1).Based on the information available (including treatment data from (b)(6) 2018), there is no documentation or indication the liberty select cycler caused or contributed to a serious adverse patient event.Additionally, there is no evidence of a machine malfunction or of the machine failing to perform as expected in relation to the event.Plant investigation: 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 follow-up for a separate event it was reported the patient was hospitalized on (b)(6) 2018 for fluid overload and possible pneumonia.Upon follow up the pdrn confirmed the patient¿s hospitalization for fluid overload.Reportedly the patient went on vacation and did not perform pd therapy (duration unknown).The pdrn believes the patient gained weight and developed signs of swelling, which lead to the hospitalization.The patient currently remains hospitalized, and is continuing to perform/undergo pd therapy.No additional information was available during the call.A diagnosis of pneumonia could not be confirmed as the discharge summary is unavailable.

• 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: 7855583
• MDR Text Key: 119535359
• Report Number: 2937457-2018-02627
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/07/2018

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: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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 SOLUTION; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention