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

Catalog Number 180020

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

Patient Problems Pneumonia (2011); Uremia (2188)

Event Date 12/18/2013

Event Type  Injury  

Event Description

The associated clinic for the peritoneal dialysis patient reported that he was non-compliant with dialyzing and regulating fluid intake following hernia repair surgery on (b)(6) 2013.Pre-operative clinic progress notes state the patient would have a low post-operative fill volume with no need to transfer from peritoneal to hemodialysis.The pt's non-adherence to his prescribed treatment resulted in fluid overload, reportedly leading to pneumonia.There is no mention of fluid overload in the hospital discharge summary.The pt was hospitalized from (b)(6) 2013 due to bacterial pneumonia (organism unspecified), uremia, and hypoglycemia.He presented with altered mental status and had hyperkalemia, nausea, and vomiting.Per the hospital discharge summary, the pt received a course of zosyn, azithromycin, and cipro for the pneumonia.Upon discharge, these were discontinued and the pt was prescribed a 10-day course of moxifloxacin.The pt was in much better condition upon discharge, with no complaint of cough or shortness of breath.Blood glucose was improved and the insulin pump was resumed, and the pt was eating meals with only mild nausea and no vomiting.Physical examination revealed lungs were clear.Cv-rrr; 1+ edema.The pt is fine now.

Manufacturer Narrative

Based on the info provided, it does not appear the device caused or contributed to the reported event.Medical records were provided and are being reviewed by the post market clinical staff and physician.The device has not been returned for physical evaluation and a plant investigation is still ongoing.A supplemental report will be submitted upon completion of the medical record review and the plant investigation.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 7816999751
• MDR Report Key: 3634602
• MDR Text Key: 17843407
• Report Number: 2937457-2014-00139
• 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: Unknown
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/31/2013

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
• Device Catalogue Number: 180020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2013
• Initial Date FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 27 YR