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

Model Number IPN000320

Device Problem Failure to Run on Battery (1466)

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

Event Date 03/07/2023

Event Type  malfunction  

Event Description

It was reported that the pump lost power while being used on a patient during transport.As a result, the pump was switched out.There was no harm or injury to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Qn#(b)(4).Corrected data: after review, it was discovered that the same event was reported by two different sales reps; therefore, this report will be retracted.The event is reported in mdr 3010532612-2023-00158.

Event Description

It was reported that the pump lost power while being used on a patient during transport.As a result, the pump was switched out.There was no harm or injury to the patient.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16547733
• MDR Text Key: 311522744
• Report Number: 3010532612-2023-00167
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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-0500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2023
• 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