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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Sepsis (2067)
Event Date 02/05/2021
Event Type  Death  
Event Description
A patient contact reported to fresenius that a peritoneal dialysis (pd) patient on continuous cyclic pd {ccpd) therapy on the liberty select cycler expired.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, the patient's pd registered nurse reported this patient was hospitalized on (b)(6) 2021 for sepsis with resulting cardiac complications.It was reported the patient had significant cardiac disease {exact diagnoses unknown) prior to this event that required a coronary arterial bypass graft and stent placement.It was stated the source of the patient's sepsis was more than likely attributed to an outpatient procedure for a pd catheter (not a fresenius product) replacement on (b)(6) 2021 due to a refractory tunnel infection.It was confirmed the patient's sepsis were unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).(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
PD CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17530274
MDR Text Key321040494
Report NumberMW5137194
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 03/01/2021
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
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