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

Catalog Number RTLR180111

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

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 02/13/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).A supplemental mdr will be submitted upon receipt of medical records and plant investigation.

Event Description

A peritoneal dialysis registered nurse (pdrn) reported a peritoneal dialysis (pd) patient expired on (b)(6) 2016 due to a myocardial infarction.The patient was not on peritoneal dialysis at the time of his death.The patient's last peritoneal dialysis treatment was completed on (b)(6) 2016.The patient had not been completing pd treatment for 2 days prior to the event as he had not been feeling well.

Manufacturer Narrative

A plant investigation of the cycler was not conducted.The cycler was not repaired or replaced under this complaint.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device record review confirmed the labeling, material, and process controls were within specification.There is no documentation in the medical record supporting a possible association between the fresenius dialysis products, the event of cardiac arrest, and the outcome of death.However, there is a certain association between the patient¿s co-morbid diseases of cardiomyopathy, peripheral vascular disease, atherosclerotic heart disease, the event, and the outcome.

Event Description

Based on two pages of medical records, it appears that this (b)(6) male did not perform peritoneal dialysis therapy (pd), via intraperitoneal (ip) route with dose regimen not reported, on (b)(6) 2016 due to not feeling well.On (b)(6) 2016, the patient died at home.The primary cause of death was cardiac arrest, cause unknown, with a secondary cause of atherosclerotic heart disease.Renal replacement therapy was not discontinued prior to death, and the patient was not receiving hospice care prior to death.

• Brand Name: LIBERTY CYCLER
• Type of Device: PERITONEAL DIALYSIS SYSTEM, AUTOMATED
• 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 ; 7816999000
• MDR Report Key: 5646820
• MDR Text Key: 44942942
• Report Number: 2937457-2016-00504
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2014
• 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): Death
• Patient Age: 56 YR
• Patient Weight: 96