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

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

Patient Problems Pneumonia (2011); Vomiting (2144)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The peritoneal dialysis (pd) patient's wife requested assistance canceling the patient's treatment because the patient had to go to the emergency room (er) due to pneumonia.The patient's wife stated the pneumonia was not related to the liberty cycler.The patient's wife mentioned the patient was spitting up a few minutes ago while he was connected to the cycler.During a follow-up, the pd registered nurse (rn) stated the patient was being treating with antibiotics orally.The pdrn stated the patient has an ongoing issue with vomiting during his pd treatments.The pdrn stated there was no evidence of fluid overload or problem's with the patient's pd therapy.The patient was seen in the emergency room several times for less than 24 hours, but he was not admitted until (b)(6) 2015 for nausea and vomiting.The patient was discharged on (b)(6) 2015.The pdrn believes the patient's hospitalization was related to his ongoing issue with pneumonia, but she did not have his discharge information.

• 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.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5357050
• MDR Text Key: 35617279
• Report Number: 2937457-2016-00022
• 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
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 83