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

Catalog Number RTLR180111

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

Patient Problems Chest Pain (1776); Myocardial Infarction (1969)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

The cycler was returned for evaluation for the unrelated problem of a fluid temperature alarm.A visual inspection of the returned cycler exterior showed no sign of physical damage.During set-up of a simulated treatment a fluid temp out of range alarm occurred and the treatment was canceled.The heater tests failed.Thermistor 3 and 4 failed to activate.The ac distribution board was replaced with a known good board and the heater test passed.The known good board was removed and the faulty ac distribution board was addressed.There were no other discrepancies encountered in the internal inspection of the cycler.The cycler was repaired and returned.There was no allegation of a cycler fault on the evening of the event, however it is possible that the trip to the hospital and back may have contributed to the later device failure.

Event Description

While reporting an unrelated fluid temperature cycler alarm a peritoneal dialysis patient reported she had been taken to the hospital two nights previous due to a minor heart attack and the paramedics were not familiar with disconnecting her from the cycler so they had brought the cycler with her while she was still connected to it.During follow up with the patient's clinic it was confirmed that the patient had been hospitalized for an event and had continued peritoneal dialysis treatment while hospitalized.The nurse reported that she did not believe the patient had a heart attack but did have chest pain.Further information has been solicited but not made available.There was no allegation that a fresenius device caused or contributed to the event.

• Brand Name: LIBERTY 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: 6715459
• MDR Text Key: 80116232
• Report Number: 2937457-2017-00583
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/14/2017

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: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2016
• 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: 78 YR
• Patient Weight: 79