MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT 2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN000329
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the pump shut down while running on battery power.The pump alarmed multiple times relating to helium loss.The pump was swapped at the destination.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of helium loss alarms is not able to be confirmed.The reported issue was not able to be replicated and the pump passed functional checkout by the field service engineer.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that the pump shut down while running on battery power.The pump alarmed multiple times relating to helium loss.The pump was swapped at the destination.There was no report of patient complications, serious injury or death.

• Brand Name: AEROAUTOCAT 2 WAVE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 13451095
• Report Number: 3010532612-2022-00019
• Device Sequence Number: 5046760
• Product Code: DSP
• UDI-Device Identifier: 30801902051739
• UDI-Public: 30801902051739
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN000329
• Device Catalogue Number: IAP-0535
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown