MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Muscle Weakness (1967); Pain (1994); Urinary Tract Infection (2120); Confusion/ Disorientation (2553)

Event Date 08/22/2021

Event Type  Injury  

Event Description

A facebook social media user reported having a bad blood infection while at a fresenius clinic, resulting in hospitalization.Upon follow-up, the patient's pd registered nurse (porn) stated the patient was hospitalized for generalized weakness, confusion, and groin pain.Unspecified testing revealed the patient contracted a severe urinary tract infection (uti) which went untreated for "a prolonged period of time." a blood culture revealed the infection spread to the patients' blood stream, causing bacteremia and required several intravenous (iv) antibiotics (drugs, doses, duration, frequency not provided).The cause of the uti remains unknown, however the patient has recovered from the events.Prior to discharge on (b)(6) 2021, the patient received a peripherally inserted central catheter (picc) line for the administration of iv antibiotics at home.The patient continued to undergo continuous cyclic pd (ccpd) while hospitalized and resumed using the same liberty select cycler following discharge.The porn stated the events were unrelated to the patient's use of any device(s) and/or product(s).Based on the available information, the patient's liberty select cycler is disassociated from the events.There is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) 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: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530271
• MDR Text Key: 321076830
• Report Number: MW5137191
• Device Sequence Number: 1
• Product Code: FJS
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1