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

Model Number LIBERTY SELECT CYCLER

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

Patient Problem Myocardial Infarction (1969)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

Although alleged that fluid overload cause the nstemi and hospitalization the medical records do not reflect that.There is no documentation that the patient of fluid overload.The medical records do reflect the patient presenting to the er with sob, difficulty breathing and recurrent chest pain.The diagnosis of acute coronary syndrome with nstemi was made requiring an emergency cardiac catheterization with angioplasty and placement of a stent in the right coronary artery.There is no evidence that the liberty cycler caused or contributed to the event.The diagnosis of nstemi is the reason for the sob, difficulty breathing and chest pain which was resolved with the cardiac catheterization with angioplasty and stent placement.The alleged event is not confirmed.The reported symptom (dv up to 180% of fv) was not confirmed.A visual inspection of the cycler exterior showed that the front panel bezel gasket was drooping approximately.5 inches over the center of the front panel overlay.There were indications of dried fluid inside the cassette compartment.No burrs or sharp edges in cassette area that may have punctured a cassette membrane.An simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.The system air leak test passed.The valve actuation test passed.The load cell verification was within tolerance.There was dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the dried fluid could not be determined.Mushroom head check passed.Tested positive for glucose.An investigation of the product history records was conducted.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

Peritoneal dialysis nurse contacted technical support regarding a medical device correction letter and reported that the patient had a heart attack on (b)(6) 2017 and has been in the hospital several times.The patient¿s physician indicated that the patient¿s heart attack may be the result of a potential overfill.Patient¿s peritoneal nurse stated that treatment records were reviewed and overfill and device malfunction was not confirmed by the clinic.The patient will perform continuous ambulatory peritoneal dialysis for the evening.Additional information was solicited and received.Information in the 9 pages of received medical records were reviewed.It appears this (b)(6) male, end stage renal disease (esrd) patient on continuous cyclic peritoneal dialysis (ccpd) therapy for renal replacement therapy (rrt) presented to the emergency room on (b)(6) 2017 with complaints of shortness of breath (sob), difficulty breathing and recurrent chest pain.The patient was admitted for further evaluation and was diagnosed with acute coronary syndrome with non-st elevation myocardial infarction (nstemi).The patient underwent an emergency cardiac catheterization with angioplasty and placement of a stent in the right coronary artery without complication.The ¿patients¿ condition rapidly stabilized¿ and was felt to be back to baseline.The patient was discharged on (b)(6) 2017 with stable vital signs with instructions to continue ccpd at home.There is no indication in the received medical records to indicate the patient was fluid overloaded when admitted to the hospital (b)(6) 2017.

• 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; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7293051
• MDR Text Key: 100834535
• Report Number: 2937457-2018-00596
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2009
• 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: LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR