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

Device Problem Improper Flow or Infusion (2954)

Patient Problem Constipation (3274)

Event Type  Injury  

Event Description

A patient on peritoneal dialysis (pd) was taken to the hospital to have an enema done during a call to customer support for request for replacement cycler for ongoing drain complication.It was reported the patients pd catheter is in correct position per x-ray.Additionally, it was reported the patient has not been able to complete pd treatment with the fresenius cycler for 3 days due the drain complications.However, the patient drains well on the clinic cycler.The cycler was processed for replacement due to the reported drain complications.In additional follow-up, the patients pd nurse stated the patient had an x-ray done on (b)(6) 2021 in the emergency room (er) which showed the patient was severely constipated.Per the nurse, the constipation may have been contributing to drain complication on the cycler, but the patient was able to drain manually.The nurse reported the patient received an enema in the er and was discharged home(less than 24 hours) on miralax; not hospitalized.Additionally, the nurse stated the patient did not miss treatment for 3 days.It was reported the patient completed pd treatments partially with the cycler and finished with manual exchanges.The nurse confirmed the patient did not have any adverse effects from the cycler.The patient reportedly received the replacement cycler and is completing pd treatments without adverse effect.(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, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531391
• MDR Text Key: 321134320
• Report Number: MW5138306
• 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: 04/20/2021

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