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

Model Number LIBERTY SELECT

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

Patient Problems Angina (1710); Chest Pain (1776)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated treatment was initiated and completed on the cycler with no issues noted.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions or defects that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Clinical review: the file has been assessed for the necessity of performing a clinical investigation.Reportedly, the patient called customer service to request a replacement cycler, and reported experiencing chest pain during the last fill of dialysis regimen.The patient also reported while hospitalized it was discovered they had air in their diaphragm (details unknown).Based on the available information, no clinical investigation is required for this event as the fresenius product(s) can reasonably be excluded from the event.The patient has a history of coronary artery disease and other unspecified cardiac issues.No product malfunction was alleged, and the chest pain was attributed to pre-existing cardiac issues.Peritoneal dialysis therapy was not interrupted or discontinued and the patient is reported to have fully recovered.Should additional information become available, the need for a clinical investigation will be re-evaluated accordingly.

Event Description

This is a report of a peritoneal dialysis (pd) patient who experienced chest pain and was hospitalized for air in their diaphragm.The patient¿s peritoneal dialysis registered nurse (pdrn) stated that the patient was hospitalized for angina of unspecified origins.The cardiac catheterization performed was negative.The patient fully recovered from the event.

Manufacturer Narrative

Correction: date of event.

• Brand Name: LIBERTY SELECT CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7497808
• MDR Text Key: 107691023
• Report Number: 2937457-2018-01281
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

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
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Device Age: MO
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 90