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 Unspecified Infection (1930); Malaise (2359)

Event Date 09/29/2019

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between pd therapy on the liberty select cycler with the fmc cassette and the patient event of not feeling well with subsequent hospitalization with possible infection.However, there is no documentation in the complaint file to show a causal relationship between the patient event and use of the liberty select cycler.Although it was not confirmed, all pd patients are at increased risk of infection due to a compromised immune system.There are several causes of infection in the peritoneal cavity other than pd including abscess, pancreatitis and diverticulitis.Based on the available information and no allegation of a malfunction, deficiency or defect, the liberty select cycler and fmc cassette can be excluded as the cause of the patient not feeling well with hospitalization and possible infection.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

This is a report of a peritoneal dialysis (pd) patient that was hospitalized on (b)(6) 2019 due to malaise.The hospitalization was reported during a follow up call with the patient's wife.Upon follow up with the pd registered nurse (pdrn) it was reported that the patient was hospitalized after they were unable to complete their treatment via manuals and weren't feeling good.Pdrn confirmed patient was still at the hospital as of (b)(6) 2019.The hospital found that the patient has an infection of the peritoneal cavity area and they were placed on intravenous treatment (treatment type unspecified).The pdrn refused to provide any further information because of confidentiality reasons but indicated that the issue has nothing to do with the use of the liberty select cycler.Additional information has been requested, however, to date a response has not been received.

• 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: amaral, matthew ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9206050
• MDR Text Key: 162795700
• Report Number: 2937457-2019-03200
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 10/18/2019

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 Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• 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