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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. SMART PERFUSION PACK PRESSURE LINE; TUBING, PUMP, CARDIOPULMONARY BYPASS

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LIVANOVA USA, INC. SMART PERFUSION PACK PRESSURE LINE; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 627299201
Device Problem Device Slipped (1584)
Patient Problem Insufficient Information (4580)
Event Date 01/26/2023
Event Type  malfunction  
Event Description
Hemofilter pull pigtail tubing slipping off the luer-lok connector.
 
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Brand Name
SMART PERFUSION PACK PRESSURE LINE
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA USA, INC.
arvada CO
MDR Report Key16304494
MDR Text Key308928839
Report NumberMW5114685
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/31/2023
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 Model Number627299201
Device Catalogue Number27299201
Device Lot Number2225500088
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/03/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age7 DA
Patient SexFemale
Patient Weight3 KG
Patient EthnicityHispanic
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