MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0700

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported " no ap waveform on pump console".Additonally it was reported that the user exchanged to a second ac3.The user then exchanged the pump console for a second time to a autocat2 wave and the fos and transducer both worked.The user also reported that the patient did not sustain injury or expire.The patient's current condition is "critical".See associated mdr# 3010532612-2024-00229.

Manufacturer Narrative

Qn#(b)(4).The reported complaint of "no ap waveform" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

Event Description

It was reported " no ap waveform on pump console".Additonally it was reported that the user exchanged to a second ac3.The user then exchanged the pump console for a second time to a autocat2 wave and the fos and transducer both worked.The user also reported that the patient did not sustain injury or expire.The patient's current condition is "critical".See associated mdr# 3010532612-2024-00229.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19006742
• MDR Text Key: 339007016
• Report Number: 3010532612-2024-00230
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AUTOCAT2 WAVE; AUTOCAT2 WAVE