MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT2 WAVE ITALIAN; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0500I

Device Problem Failure to Run on Battery (1466)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

The report states while in use on a patient, "internal battery doesn't work and the pump does not work detached by the main line".The issue was resolved by "using the pump connecting to the main line".There was no patient harm or injury or delay in therapy.No patient complications.

Manufacturer Narrative

Qn#(b)(4).The reported complaint of "the internal battery doesn't work and the pump does not work detached by the main line" is not able to be confirmed.No part or recorder strip was returned to teleflex chelmsford 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.Iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance and storage of the batteries.If battery maintenance is not performed per the iabp operating instructions manual, the battery may not provide the expected minimum run time of operating power.

Event Description

The report states while in use on a patient, "internal battery doesn't work and the pump does not work detached by the main line".The issue was resolved by "using the pump connecting to the main line".There was no patient harm or injury or delay in therapy.No patient complications.

• Brand Name: AUTOCAT2 WAVE ITALIAN
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18845488
• MDR Text Key: 336977477
• Report Number: 3010532612-2024-00169
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902092190
• UDI-Public: 30801902092190
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500I
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• 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