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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS HEMODIALYSIS CATHETER PRODUCTS

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FRESENIUS HEMODIALYSIS CATHETER PRODUCTS Back to Search Results
Lot Number 10061305
Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2017
Event Type  Injury  
Event Description
Crit chamber does not fit adequately into the dialyzer, causing blood to leak around it.Unable to use crit with dialyzer.Equipment removed from service.
 
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Brand Name
HEMODIALYSIS CATHETER PRODUCTS
Type of Device
HEMODIALYSIS CATHETER PRODUCTS
Manufacturer (Section D)
FRESENIUS
MDR Report Key6629503
MDR Text Key77319265
Report NumberMW5070257
Device Sequence Number1
Product Code MSD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/07/2017
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? Yes
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Lot Number10061305
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/07/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age44 YR
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