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

Device Problem Malposition of Device (2616)

Patient Problems Muscle Weakness (1967); Confusion/ Disorientation (2553)

Event Date 03/20/2021

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was hospitalized for unknown reasons.Upon follow up, the patient's pd nurse (porn) reported this patient was hospitalized for generalized weakness and confusion.The patient was also having pd catheter (not a fresenius product) complications due to a malposition of the catheter.There was no report the patient experienced a serious injury or adverse event that could potentially cause or contribute to the malposition of the patient's pd catheter.Additionally, it was reported the patient experienced catheter complications since the start of pd therapy approximately one month ago.During this admission, it was determined the patient was unable to undergo pd therapy without assistance and the patient was transitioned to hemodialysis (hd) through an existing central vascular catheter.The patient underwent hd therapy on a hospital provided hd machine (unknown brand and model) for the duration of this admission.The patient had an uneventful hospital course and was discharged to home (exact date unknown).It was confirmed the patient's generalized weakness, confusion, pd catheter complications and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd therapy on an in-center basis, post-discharge.Based on the required information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.The catheters used by the patient are not fresenius devices.The manufacturers of the catheters, and further product information, are unknown.C-757990 (b)(6).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, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17526419
• MDR Text Key: 321137154
• Report Number: MW5133358
• 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: 04/05/2021

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