• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PD CATHETER; 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
 

UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
On (b)(6) 2022, a patient contact reported to fresenius technical services this 65-year-old female peritoneal dialysis (pd} patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler needed to discontinue a pd treatment to report to the hospital.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient's pd registered nurse, it was reported this patient needed to discontinue a ccpd treatment on her liberty select cycler on (b)(6) 2022 due to the inability to drain requiring an emergency department (ed) visit.The patient was able to safely disconnect from their liberty select cycler and was transported by emergency services to the ed where they were admitted to the hospital on the same day.The patient was diagnosed with a malposition of their pd catheter (not a fresenius product).It was affirmed the patient's malposition of her pd catheter was not caused by a serious injury or adverse event.The patient underwent a reposition of her pd catheter during this hospitalization and was able to continue ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2022.It was confirmed the patient's ma i position of her pd catheter was not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.(b)(4).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
PD CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17488352
MDR Text Key320683510
Report NumberMW5121051
Device Sequence Number1
Product Code FJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/30/2022
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 Received08/09/2023
Patient Sequence Number1
Patient Age65 YR
-
-