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

Model Number IPN000320

Device Problems Failure to Run on Battery (1466); Complete Loss of Power (4015)

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

Event Date 04/25/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reporting that during aircraft transportation while in use on a patient, the iabp was plugged into the aircraft inverter power throughout the transport.After being unplugged from the power source, the iabp started to alarm for low battery, the screen went blank, and the pump stopped pumping.The issue was resolved by plugging the iabp into the wall.No harm or injury to the patient.No medical intervention required.Per the customer, the current condition of the patient is unknown.

Manufacturer Narrative

(b)(4).The reported complaint of "when on battery power the screen went blank and the low battery alarm activated" is not able to be confirmed.No part 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.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reporting that during aircraft transportation while in use on a patient, the iabp was plugged into the aircraft inverter power throughout the transport.After being unplugged from the power source, the iabp started to alarm for low battery, the screen went blank, and the pump stopped pumping.The issue was resolved by plugging the iabp into the wall.No harm or injury to the patient.No medical intervention required.Per the customer, the current condition of the patient is unknown.

• Brand Name: AUTOCAT2 WAVE
• 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: 16956787
• MDR Text Key: 315546516
• Report Number: 3010532612-2023-00262
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0535
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2023
• 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: N/A.; N/A.
• Patient Age: 86 YR
• Patient Weight: 61 KG