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

Catalog Number LC002581

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

Patient Problems Myocardial Infarction (1969); No Code Available (3191)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

The patient's medical records were requested and had not been received at the time of this report.If the medical records should become available, a supplemental report will be submitted.A supplemental report will be submitted upon completion of plant's investigation.

Event Description

A peritoneal dialysis (pd) reported he did not do pd treatment last month because he was completing hemodialysis therapy due to a surgery to remove part of his stomach.During a follow-up, the patient's peritoneal dialysis registered nurse reported the patient's surgery to remove part of his stomach was scheduled and in response to issues discovered during the patient's hospitalization.The patient was hospitalized due to a mild heart attack.The pdrn confirmed the patient was not connected to the machine at the time of his heart attack.The date of the patient's hospitalization was unknown.The patient was continued pd treatment.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; walnut creek, CA 02451-1457 ; 7816999000
• MDR Report Key: 5301794
• MDR Text Key: 33705236
• Report Number: 2937457-2015-01706
• 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
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: LC002581
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR