MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 10/09/2014

Event Type  Injury  

Event Description

Patient called htrn, (b)(6), to report cycler malfunction.Patient stated that her liberty cycler gave her an alarm that the solution was too hot and needed to cool down.She states that she then felt burning in her lower abdomen, groin and upper thighs.She had already called technical support, who advised her to call her nurse afer walking her through the procedures to drain and disconnect safely from the machine.She said technical support told her not to use the cycler anymore and they would be sending another to her the next morning.The patient was advised to go to the er by rn.Patient was discharged from er without significant findings.Home therapy program manager, medical director, md, director of operations, and regional quality manager notified.Patient was called to follow up after er visit by kathy, htrn, and patient told her at that time that she had been feeling "warmer and warmer" over the last two weeks, but didn't report it because she thought she might have an infection.Htrn to continue to follow up with patient and, per md order, will draw blood cultures if patient has any indication at next clinic visit ((b)(6) 2014).

• Brand Name: LIBERTY CYCLER
• Type of Device: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; 2637 shadelands dr.; walnut creek CA 94598
• MDR Report Key: 4329792
• MDR Text Key: 5212077
• Report Number: 4329792
• Device Sequence Number: 1
• Product Code: FKX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2014
• Distributor Facility Aware Date: 10/09/2014
• Event Location: Home
• Date Report to Manufacturer: 10/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 21