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	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the machine displayed helium loss alarm while pumping during preventative maintenance.No report of patient inv olvement.The pneumatic control system has been replaced.The machine was returned to service.
Event or Problem Description
It was reported that the machine displayed helium loss alarm while pumping during preventative maintenance.No report of patient inv olvement.The pneumatic control system has been replaced.The machine was returned to service.
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a pcs assembly.All valves were individually tested by powering them on and off using an external power supply, and no abnormalities were noted.The pcs assembly was unable to be functionally tested due to the sheared screw in the cold trap port.A device history record (dhr) review was conducted for the serial number/lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of helium loss alarm is confirmed.Upon receipt of the returned pcs assembly, the cold trap port was noted with a sheared screw stuck inside, which can cause the reported issue.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 sheared screw in the cold trap port.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.Other remarks: n/a.Corrected data: n/a.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15772991
• Report Number: 3010532612-2022-00492
• Device Sequence Number: 3062117
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/19/2022
• 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
• Patient Sex: Unknown