Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERITONEAL DIALYSIS (PD); CATHETER, PERITONEAL, LONG-TERM INDWELLING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PERITONEAL DIALYSIS (PD); CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problems Infusion or Flow Problem (2964); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Other  
Event Description
On (b)(6) 2023, this patient on peritoneal dialysis (pd) contacted customer support for a power issue with the fresenius cycler.The cycler was replaced due to the reported issue.Additionally, during the call the patient mentioned experiencing intermittent ¿draining slowly¿ message with the cycler for one month.In additional follow-up with the patient¿s pd nurse, it was reported that the patient was having pd catheter (not a fresenius product) malfunction.It was stated the patient was able to fill with dialysate but had difficulty draining.As a result, the patient was reabsorbing fluid and then was not able to dialyze.Subsequently, the patient was hospitalized on (b)(6) 2023 due to pd catheter malfunction.The patient underwent removal of the pd catheter and was transitioned to hemodialysis for renal replacement needs.The patient was discharged on (b)(6) 2023 and has recovered.The nurse confirmed the reported drain complications on the cycler was not a cycler issue at all but due to malfunctioning pd catheter.The nurse indicated the patient did not have any adverse effects due to an issue with fresenius products.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERITONEAL DIALYSIS (PD)
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
MDR Report Key17298077
MDR Text Key318801526
Report NumberMW5119247
Device Sequence Number1
Product Code FJS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
-
-