MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Overfill (2404)

Patient Problems Pneumonia (2011); Hypervolemia (2664)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be filed upon completion of the manufacturer's investigation.

Event Description

A peritoneal dialysis nurse reported that the patient was hospitalized for pneumonia on (b)(6) 2018.The nurse confirmed that the patient had issues with the cycler not draining properly which resulted in overfill.The patient continued with peritoneal dialysis therapy in the hospital.The patient is currently recovering.The patient has been utilizing peritoneal dialysis sine (b)(6) 2017.

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between the event of fluid volume overload and pneumonia with subsequent hospitalization and the liberty select cycler.There is an allegation by the pdrn that the cycler was not properly draining the patient, however, there is no documentation in the complaint file to show a causal relationship between the fluid volume overload and pneumonia and the liberty select cycler.Additionally, the patient has several co-morbidities that could have contributed to the pneumonia and fluid volume overload as well as fibrin and an infection.Per the pdrn the pneumonia is not attributed to pd therapy.The device was not returned and the causal event of the pneumonia and fluid volume overload is undetermined.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
• 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: 7448677
• MDR Text Key: 106135052
• Report Number: 2937457-2018-01111
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 74