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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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UNKNOWN PERITONEAL DIALYSIS; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354)
Patient Problems Cellulitis (1768); Unspecified Infection (1930)
Event Date 12/26/2021
Event Type  Injury  
Event Description
It was reported that a peritoneal dialysis (pd) patient had an infection and received antibiotics in the hospital.Upon follow up, the patient's pd nurse stated the patient was hospitalized for cellulitis of the right foot, unrelated to pd therapy.While hospitalized, the patient had a pd catheter (not a fresenius product) leak due to the cuff becoming non-adhered to the patient.The patient underwent replacement of the pd catheter and was receiving antibiotics for cellulitis and pd catheter leak.The nurse confirmed the patient did not have peritonitis.The patient was discharged on (b)(6)2021 and has reportedly recovered.Per the nurse, the patient is completing pd treatments with the fresenius cycler without any adverse effects.Based on the available information, there is no allegation or indication that a fresenius device or product issue caused or contributed to a serious patient harm or injury.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(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 DIALYSIS
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
UNKNOWN
MDR Report Key17530181
MDR Text Key321134084
Report NumberMW5137101
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 01/03/2022
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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