MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

Catalog Number (RTLR) 180111

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

Patient Problem Myocardial Infarction (1969)

Event Date 10/05/2015

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient reported she was hospitalized.Subsequent follow up with the peritoneal dialysis registered nurse (pdrn) revealed on (b)(6) 2015 the patient experienced chest pains prior to commencement of pd treatment.The pdrn reported the patient was seen in a local emergency room and was discharged home.The patient spent less than 23 hours in the local hospital.The patient returned home and connected to the liberty cycler to begin pd therapy.The patient then reported worsening of chest pains and disconnected from pd therapy and returned to the local hospital.Upon return to the local hospital, the patient was found to have experienced a myocardial infarction.The patient subsequently underwent triple bypass surgery on an unknown date and was discharged from hospital on (b)(6) 2015.

Manufacturer Narrative

The cycler was returned for evaluation.An external visual inspection determined that there were no signs of any physical damage.There were no discrepancies encountered in the internal inspection of the cycler.The cycler underwent simulated treatment and no alarms or problems occurred.A device history review was performed and found no non-conformance reports or other abnormalities during the assembly of this lot.The product involved met current specifications.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The system level review of the liberty cycler and concomitant products found no indication that the products caused or in any way to the clinical event.The complaint was not confirmed.Medical records were reviewed and do not contain any dialysis treatment records.There was no documentation that indicates a causal relationship between the liberty cycler and the patient's chest pain or cardiac disease.Medical records reveal the patient's chronic cardiac history and coronary artery disease were the cause of patient's chest pain and subsequent coronary artery bypass graft.

Event Description

The following is from medical records provided by the patient's treatment facility.The patient presented to the hospital initially with chest pain and was diagnosed with anemia that was treated with two units of packed red blood cells and discharged home.The patient returned to the hospital again a few days later and was diagnosed with an acute myocardial infarction.Multi-vessel disease was found and a triple coronary artery bypass graft was performed.The patient developed postoperative thrombocytopenia and anemia.The patient improved and eleven days after admission was discharged to a long term nursing facility.Discharge diagnosis included acute coronary syndrome with symptomatic critical left main disease, status post triple coronary artery bypass graft.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS USA, INC. ; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5331991
• MDR Text Key: 34690471
• Report Number: 2937457-2015-01736
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: (RTLR) 180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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
• Patient Age: 73 YR