MAUDE Adverse Event Report: TELEFLEX / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) AC3 OPTIMUS IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IAP0700

Device Problems Unable to Obtain Readings (1516); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 event description (ekg issues): patient has had iabp in axillary site since (b)(6) 2023.On (b)(6) 2023, the iabp, which had been triggered by the ekg, stopped triggering.The ekg strip was blank on the iabp monitor.Ekg cord removed from iabp, and new cord placed.New iabp cord showed an ekg on the iabp screen and started triggering from the ekg again; on (b)(6) 2023.Reference reports mw5117820, mw5117821, mw5117823, mw5117824, mw5117825, mw5117826, mw5117827.

• 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 Key: 17002054
• MDR Text Key: 316020699
• Report Number: MW5117822
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IAP0700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention