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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PERITONEAL CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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UNKNOWN PERITONEAL CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problems Complete Blockage (1094); Malposition of Device (2616); Migration (4003)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
A peritoneal dialysis (pd) patient reported that they were receiving a patient line is blocked soft alarm during fill 1 of 4 of their pd treatment.The patient stated that they spoke with their peritoneal dialysis registered nurse (pdrn) and they advised them to call technical support to have their cycler replaced because it is an old serial number.Upon follow up, the pdrn stated that the patient was sent to the surgeon for flow issues, pd catheter tip migration, and fibrin was found.The pdrn stated that the issues were fixed and the patient resumed treatment on the cycler.Upon further follow-up, the patient confirmed the pd catheter (not a fresenius product) had fibrin and was malpositioned requiring pd catheter adjustment.The patient reported having long drains while using the liberty select cycler.However, the patient stated they have not had any adverse effects from using the cycler or any other fresenius device, or product.The patient continues pd therapy with the same cycler without any harm or injury.(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
PERITONEAL CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17537516
MDR Text Key321164896
Report NumberMW5144394
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 08/17/2020
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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