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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) AC3 OPTIMUS IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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TELEFLEX / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) AC3 OPTIMUS IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number IAP0700
Device Problems Backflow (1064); Deflation Problem (1149); Inflation Problem (1310); Material Rupture (1546); Pressure Problem (3012)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/03/2023
Event Type  Injury  
Event Description
On (b)(6) 2023 event description (balloon rupture): iabp alarming.The alarm was " ekg trigger loss" the balloon was not inflating with each complex.A line pressures stable.The iabp was on "auto pilot" and ekg was showing up on screen.The iabp started alarming " high pressure" and was erratically inflating and deflating.All lines rechecked again from the patient to the pump.Noted nothing wrong.The helium line then flooded with blood.Patient was sent to the operating room to replace the balloon.Reference reports mw5117821, mw5117822, mw5117823, mw5117824, mw5117825, mw5117826, mw5117827.
 
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Brand Name
AC3 OPTIMUS IABP
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
morrisville NC 27560
MDR Report Key17002037
MDR Text Key316016576
Report NumberMW5117820
Device Sequence Number1
Product Code DSP
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 05/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIAP0700
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/24/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
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