MAUDE Adverse Event Report: FRESENIUS USA, INC. LIBERTY PD DIALYSIS MACHINE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY DEVICE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/01/2018

Event Type  Injury  

Event Description

I have had seven pd dialysis machines which have failed and are supplied by fresenius corp over the past 10 months.Recently, i attended a continuing education conference (which is required by law) where i was left without proper dialysis as two machines failed just before the conference and during the conference.Upon return from the conference, i required hospitalization on an emergency basis to save my life.I believe these machines are unreliable and should be investigated.Dr (b)(6) od, bsc.

• Brand Name: LIBERTY PD DIALYSIS MACHINE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY DEVICE
• Manufacturer (Section D): FRESENIUS USA, INC. ; CA
• MDR Report Key: 7591217
• MDR Text Key: 110865682
• Report Number: MW5077784
• Device Sequence Number: 7
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/10/2018
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 62 YR
• Patient Weight: 92