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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN LIBERTY SELECT CYCLER, PD CATHETER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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UNKNOWN LIBERTY SELECT CYCLER, PD CATHETER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported to fresenius during followup for a liberty select cycler alarm that this patient was hospitalized from (b)(6) 2021.No additional information provided at intake.Follow-up with the patient's peritoneal dialysis registered nurse (porn) revealed the patient's liberty select cycler was working as expected.The porn stated the events were caused by a mixture of user error, and the patient's peritoneal dialysis (pd) catheter (not a fresenius product) was found to be mal-positioned.The patient was hospitalized on (b)(6) 2021 for pre-surgery testing (specifics not provided), and successfully underwent a pd catheter revision on (b)(6) 2021.The patient was kept overnight following surgery to monitor the pd catheters' function.Ccpd therapy occurred on the evening of (b)(6) 2021 without issue, and the patient was discharged home on (b)(6) 2021 in stable condition.The porn reported the events were unrelated to any fresenius device(s) and/or product(s) malfunction or deficiency.The patient has recovered from the events and resumed ccpd therapy at home.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
LIBERTY SELECT CYCLER, PD CATHETER
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
UNKNOWN
MDR Report Key17526926
MDR Text Key321263204
Report NumberMW5133863
Device Sequence Number1
Product Code FKX
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 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
Treatment
FJS
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