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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING
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UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Event Description
A peritoneal dialysis (pd) patient reported experiencing reported drain complications, chills and abdominal discomfort during their continuous cyclic peritoneal dialysis (ccpd).Upon follow up with the peritoneal dialysis registered nurse (pdrn) reported that the patient was hospitalized (admission date unknown) for peritonitis and a malfunctioning peritoneal dialysis catheter (not a fresenius product).Peritoneal effluent cultures were obtained and the results were positive for pseudomonas.The pdrn reported the patient was treated with antibiotics, however details regarding the drug, dosage, frequency and duration is unknown.The patient continued to perform pd therapy while hospitalized, however it is unknown of any fresenius device(s) or product(s) were utilized.The hospital course, discharge disposition and current mode of renal replacement therapy (rrt) is unknown, however the pdrn reported causality was attributed to a hole on the end of the peritoneal dialysis catheter (not a fresenius product).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17525069
MDR Text Key321141795
Report NumberMW5132011
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 05/25/2018
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 Received08/12/2023
Patient Sequence Number1
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