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

Model Number IPN000320

Device Problem Gas Output Problem (1266)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The report states "error detected during preventative maintenance.The value of helium psi of the canister read by the pump was fixed and incorrect.The pump display always the same value.The helium reg.Assy.Has been replaced.The machine got back to service." no report of patient involvement.

Manufacturer Narrative

Qn# (b)(4).Additional information received on 27 dec 2022 states, "the error has been detected during preventive maintenance, while checking the helium psi value displayed by the pump (fixed).No alarm has been displayed by the pump.After having replaced the helium re.Assy the pump returned to service correctly." returned for investigation was an ac2 helium regulator assembly (p/n 77-3007-001, s/n (b)(6).The sample was returned in a white cardboard box with protective shipping packaging.Visual inspection of the helium regulator assembly was performed and no abnormality was noted.The helium regulator assembly was installed into a known good lab inventory ac2 for functional testing.The pump powered up normally.The system was able to detect helium pressure and displayed the proper helium status.Pumping was initiated.A source side helium leak test was performed and passed.The pump was left to run for over an hour and the helium tank pressure was dropped by 5 psi, which is an expected outcome after several drain tasks.The helium regulator assembly functioned as intended.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.The report complaint of helium tank pressure incorrect was confirmed by the field service representative; however, the returned helium regulator passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

Event Description

The report states "error detected during preventative maintenance.The value of helium psi of the canister read by the pump was fixed and incorrect.The pump display always the same value.The helium reg.Assy.Has been replaced.The machine got back to service." no report of patient involvement.

• 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: 16016556
• MDR Text Key: 308117709
• Report Number: 3010532612-2022-00569
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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