MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Renal Failure (2041)

Event Date 05/27/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).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 report will be submitted upon completion of the plant¿s investigation.Clinical review of the medical records provided show the patient died of an acute myocardial infarction, cardiac arrest, esrd and diabetes mellitus type i.Labs provided were as expected for a patient with esrd, of note was the patient¿s ferritin level which was more than twice normal value.There was no allegation against fresenius products and the cause of death was unlikely related to peritoneal dialysis therapy occurring at the time of death.

Event Description

A peritoneal dialysis nurse reported a patient experienced a cardiac arrest and subsequently expired while connected to the cycler.The following is from medical records provided by the patient's treatment facility.The esrd death notification reported the cause of death as acute myocardial infarction with no secondary causes.The patient was not on hospice care at the time of death.The death certificate list causes of death as: cardiac arrest, end stage renal failure and type i diabetes.

Manufacturer Narrative

A visual inspection was performed on the returned device and there were no signs of any physical damage with the received cycler.An internal inspection was performed and there were no discrepancies encountered in the internal inspection of the cycler.Simulated testing was performed and the device performed without failures.Device history review was performed and found no non-conformance reports or other abnormalities during the manufacturing process.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 of a causal relationship between the products and the patient event.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5748931
• MDR Text Key: 48151147
• Report Number: 2937457-2016-00662
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Other Device ID Number: UDI: 00840861100972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2012
• 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: CARDIZEM
• Patient Outcome(s): Death
• Patient Age: 34 YR
• Patient Weight: 98