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

Model Number	IPN000320
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "iabp failure.During transport the iabp therapy screen became inoperable.While loading the patient into the ambulance for transit to the remote landing zone the iabp screen flashed once blank but immediately returned, all connections were assessed and deemed to be appropriate.After loading the patient into the aircraft and prior to start up the screen again went blank and all control was lost, this time the iabp actually stopped assisting, during trouble shooting the iabp started to trigger spontaneously and appeared to correspond with the cardiac rhythm on the zoll monitor.There was a brief period of hypotension and bradycardia that was self-limiting and returned to normal without therapy.[physician] was contacted and on the phone while trouble shooting and return of mechanical assist but no active therapy screen.He advised to continue to upmc shadyside.Upon landing at upmc shadyside, the cticu staff and an iabp was on the helipad and an immediate swap of machine was done while the patient remained in the aircraft.There were no further instances of hemodynamical instability".Additional information received stated that "there was no intervention.The pump shut off for several seconds however the screen remained white.While the screen remained blank, the trigger light, power light, ratio light, and audible pumping were noted.Patient heart rate was 58, blood pressure 74/41.Bradycardia/hypotension seemed to be during the several seconds of being off".Patient condition reported as "fine".Associated to mdr 3010532612-2022-00335.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "iabp failure.During transport the iabp therapy screen became inoperable.While loading the patient into the ambulance for transit to the remote landing zone the iabp screen flashed once blank but immediately returned, all connections were assessed and deemed to be appropriate.After loading the patient into the aircraft and prior to start up the screen again went blank and all control was lost, this time the iabp actually stopped assisting, during trouble shooting the iabp started to trigger spontaneously and appeared to correspond with the cardiac rhythm on the zoll monitor.There was a brief period of hypotension and bradycardia that was self-limiting and returned to normal without therapy.[physician] was contacted and on the phone while trouble shooting and return of mechanical assist but no active therapy screen.He advised to continue to upmc shadyside.Upon landing at upmc shadyside, the cticu staff and an iabp was on the helipad and an immediate swap of machine was done while the patient remained in the aircraft.There were no further instances of hemodynamical instability".Additional information received stated that "there was no intervention.The pump shut off for several seconds however the screen remained white.While the screen remained blank, the trigger light, power light, ratio light, and audible pumping were noted.Patient heart rate was 58, blood pressure 74/41.Bradycardia/hypotension seemed to be during the several seconds of being off".Patient condition reported as "fine".Associated to mdr 3010532612-2022-00335.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "display head screen white" is confirmed.Returned for investigation was an autocat2 series display head assembly.The sample was returned in a brown cardboard box and was further enclosed in a white cardboard box with protective shipping packaging and an esd bag.Visual inspection of the display head was performed, and no abnormalities were noted.The display head was installed onto a known good autocat2w for functional testing.Upon power-up, the pump displayed a white screen; however, all buttons responded properly to being pressed.Pumping was initiated.The pump was left to run for approximately 1 hour and no alarms or errors were noted.Visual inspection of the display head assembly internal hardware was performed, and no abnormalities were found.All connectors were properly seated.Upon power-up, the pump displayed a white screen.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 white screen.The cause of the white screen is undetermined.No further action required at this time.This will be monitored for any developing trends.Corrected data: section d4 catalog number: corrected from iap-0500 to iap-0535.Section d4 unique identifier (udi) number: corrected from (b)(4) to (b)(4).This information was received from customer after initial report was submitted.

• Brand Name: AEROAUTOCAT 2 WAVE
• 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: 15325279
• Report Number: 3010532612-2022-00340
• Device Sequence Number: 17763428
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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: IPN000320
• Device Catalogue Number: IAP-0535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/27/2022
• 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