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

Model Number 180343

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

Patient Problem Myocardial Infarction (1969)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

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.Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the serious adverse event of myocardial infarction, which warranted hospitalization.The etiology of the event is unknown; therefore, causality cannot be established.However, during follow-up, the patient reported the event was unrelated to the utilization of the liberty select cycler or any fresenius device(s) or product(s).Additionally, the patient continues to utilize the same liberty select cycler as before the event, without any reported issues or allegations of machine malfunction or deficiency.Based on the limited information available, and no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency, defect or malfunction occurred.The liberty select cycler can be excluded as the cause of the patient¿s serious adverse event.

Event Description

It was reported that a peritoneal dialysis (pd) patient had a heart attack and disconnected from the cycler to go to the hospital.The patient contact requested steps for canceling treatment.Technical support advised rebooting the cycler and guided the patient contact through the treatment end process.During follow-up, the patient confirmed experiencing a myocardial infarction during ccpd therapy on (b)(6) 2020.However, the patient stated the myocardial infarction had ¿nothing to do with¿ the liberty select cycler or any other fresenius device or product used.The patient stated continuing to use the same liberty select cycler and has recovered from the event.Additional information was requested, however it was not available.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9615898
• MDR Text Key: 176025718
• Report Number: 2937457-2020-00135
• 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: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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
• Patient Outcome(s): Hospitalization