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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW FIBEROPTIX ULTRA 8 IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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TELEFLEX INCORPORATED ARROW FIBEROPTIX ULTRA 8 IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number IPN000254
Device Problem Backflow (1064)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2018
Event Type  malfunction  
Event Description
Intra-aortic balloon pump (iabp) catheter with blood in the gas phase of the device.The catheter was inserted with some difficulty in the operating room to support the patient after a difficult wean from cardiopulmonary bypass.Upon initiation the perfusion team noticed blood in the gas line and immediately discontinued iabp support.Device was removed and retained.A new catheter was opened, inserted successfully and support initiated without reported incident.Manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter).We are unable to identify who we gave this tubing to (vendor rep.) or when.
 
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Brand Name
ARROW FIBEROPTIX ULTRA 8 IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key8124120
MDR Text Key129057761
Report Number8124120
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902007247
UDI-Public(01)00801902007247
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/20/2018,11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F1880020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/20/2018
Event Location Hospital
Date Report to Manufacturer12/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age25185 DA
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