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

Model Number	IPN000324
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the machine displayed helium loss alarm while pumping during preventive maintenance.No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Returned for investigation was an autocat2 pcs assembly.The sample was returned in a brown cardboard box with protective shipping packaging.Visual inspection of the pcs assembly was performed.Several of the ports appeared dirty with an unknown substance.The pcs assembly was installed into a known good lab inventory ac2 for functional testing.The pump started up successfully.The leak test was performed and failed.During the test, the pump alarmed "possible helium loss 3 (2)".The pcs assembly was removed from the pump.Each valve was connected to a 12v dc power supply to check proper function.V2, v3, and v4 responded properly to the 12v supplied with an audible click, indicating proper valve function.V1 did not respond properly.Visual inspection of the pcs assembly internal hardware was performed.V1 was noted to be loose, which could have caused the helium loss alarm.A small amount of potentially blood was also noted in v1.A significant amount of dried, flaky white substance was noted near the threads of v4.This was potentially old teflon tape.Due to the loose valve, the valves were reattached properly, and the pcs was retested.All valves now responded properly to the 12v supplied.Pumping was initiated and no alarms were noted in 30 minutes.In summary, the reported complaint of helium loss alarm is confirmed.The v1 vent valve was found to be loose during the complaint i nvestigation, which potentially caused the reported alarm.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the loose vent valve.The root cause of how the valve became loose is undetermined.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported that the machine displayed helium loss alarm while pumping during preventive maintenance.No patient involvement reported.

• Brand Name: AUTOCAT2 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 27560
• MDR Report Key: 14941233
• Report Number: 3010532612-2022-00238
• Device Sequence Number: 17282541
• Product Code: DSP
• UDI-Device Identifier: 30801902092190
• UDI-Public: 30801902092190
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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
• Device Model Number: IPN000324
• Device Catalogue Number: IAP-0500I
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 07/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown