MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient experienced a drain complication encountered please check patient line and drain line message during drain 0 of 5 while hospitalized.Technical support confirmed the patient was already empty and assisted with bypassing to fill 1.The patient then started to fill.Upon follow up, the patient stated being hospitalized for a catheter (not a fresenius product) related infection.The catheter was subsequently removed and the patient has fully recovered.The patient stated the infection was not related to pd therapy or fresenius product usage.Additional information was requested; however, it was not available.Based on the available information, the patient's liberty select cycler is disassociated from the event(s).There is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event related to a fresenius device(s) or product(s) occurred warranting further investigation.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533575
• MDR Text Key: 321148914
• Report Number: MW5140479
• Device Sequence Number: 1
• Product Code: GBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1