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

Catalog Number RTLR180111

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

Patient Problem Myocardial Infarction (1969)

Event Date 09/08/2016

Event Type  Injury  

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.

Event Description

A peritoneal dialysis (pd) patient's contact reported that the patient experienced a heart attack while on the cycler and had to disconnect and cancel treatment.Additional information received from the patient's pd nurse confirmed that the patient was hospitalized for a st-elevation myocardial infarction.The patient was discharged from the hospital on (b)(6) 2016.The patient's medical records have been requested but have not yet been made available.

Manufacturer Narrative

A return product investigation was not performed as the cycler was not replaced in the complaint for the reported symptoms.Field service investigation is not performed on cyclers.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.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): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5991573
• MDR Text Key: 56065218
• Report Number: 2937457-2016-01040
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• 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: UDI: 00840861100972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2016
• Date Device Manufactured: 11/13/2009
• 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: PD FLUID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 100