MAUDE Adverse Event Report: BAXTER AUTOMATED P.D. SYSTEM; PERITONEAL DIALYSIS SYSTEM

Device Problems Grounding Malfunction (1271); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Nerve Damage (1979); Pain (1994); Pressure Sores (2326); Shock from Patient Lead(s) (3162)

Event Date 02/22/2016

Event Type  Injury  

Event Description

Reporter alleges three weeks into using an automated p.D system.She received undesireable shocks from the device.This shocks occurred especially during the third cycle and she reached out to baxter to inform them about the undesirable shocks she was receiving from the device.She was advised the device was not grounded and that was the cause of the inappropriate shocks.Caller alleges she was hospitalized for approximately 9 days and was switched to hemodialysis.She also advised she had sores on lower extremities and nerve damage on upper extremities; she was prescribed gabapentin for nerve damage, tramadol for pain and xanax for stress.

• Brand Name: AUTOMATED P.D. SYSTEM
• Type of Device: PERITONEAL DIALYSIS SYSTEM
• Manufacturer (Section D): BAXTER
• MDR Report Key: 6968464
• MDR Text Key: 90088638
• Report Number: MW5072884
• Device Sequence Number: 1
• 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: Other
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 52