MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AEROAUTOCAT2 WAVE ITALIAN; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN000333
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
Event or Problem Description
There was no patient involvement.It was reported that "helium loss" was displayed by the machine.As a result, the pcs was replaced, and the machine was returned to service.
Additional Manufacturer Narrative
(b)(4).The reported complaint of helium loss alarm is confirmed.Returned for investigation was a pcs assembly.The sample was returned in a brown cardboard box with protective shipping packaging.Visual inspection of the pcs assembly was performed, and dried blood/condensation was noted inside the manifold and pneumatic valves which potentially created a blockage inside the pneumatic system.All valves were individually tested by powering them on and off using an external power supply, and the drain valve was found to very sticky (delayed response).A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.However, the received product did not meet specifications during the complaint investigation due to the dried blood buildup inside the pcs assembly.The root cause of how the condensation buildup or blood entered the pcs assembly is undetermined.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
There was no patient involvement.It was reported that "helium loss" was displayed by the machine.As a result, the pcs was replaced, and the machine was returned to service.

• Brand Name: AEROAUTOCAT2 WAVE ITALIAN
• Common Device Name: 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: marling heaton ; 3015 carrington mill blvd; morrisville, MA 27560
• MDR Report Key: 14659317
• Report Number: 3010532612-2022-00235
• Device Sequence Number: 20306814
• Product Code: DSP
• UDI-Device Identifier: 30801902091773
• UDI-Public: 30801902091773
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: IPN000333
• Device Catalogue Number: IAP-0535I
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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