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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS MEDTRONIC DLP 24 FR RIGHT ANGLE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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MEDTRONIC PERFUSION SYSTEMS MEDTRONIC DLP 24 FR RIGHT ANGLE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 24 FR SINGLE STAGE VENOUS CANNUL
Device Problems Coagulation in Device or Device Ingredient (1096); Obstruction of Flow (2423)
Patient Problem Insufficient Information (4580)
Event Date 12/11/2020
Event Type  Injury  
Event Description
Poor venous drainage with increasing cvp and decreasing nirs noted while on bypass.Svc and ivc cannulas removed intraoperatively and both were full of clot even though appropriate acts had been maintained.The patient was subsequently recannulated with new cannulas.Fda safety report id # (b)(4).
 
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Brand Name
MEDTRONIC DLP 24 FR RIGHT ANGLE VENOUS CANNULA
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC PERFUSION SYSTEMS
minneapolis MN
MDR Report Key11027432
MDR Text Key222374385
Report NumberMW5098422
Device Sequence Number1
Product Code DWF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/15/2020
2 Devices were Involved in the Event: 1   2  
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 Date06/10/2023
Device Model Number24 FR SINGLE STAGE VENOUS CANNUL
Device Catalogue Number69324
Device Lot Number2020060456
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age14 YR
Patient Weight86
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