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

Model Number	IPN000325
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that an "unable to refill" alarm went off during clinical use with ecmo.After confirming the alarm, the user attempted to press the drive start key but could not.He/she tried to restart the intra-aortic balloon pump (iabp) by nr.-> me -> me, but the iabp did not restart.Therefore, the iabp was replaced with a back-up one in the facility.There was no report of patient complications, serious injury or death.The technical engineer of dvx, the distributor, visited to the facility and confirmed operation of the iabp using the simulator set in the eicu equipment room.Leak test, various signal input confirmation, switching operation / drive confirmation, drain / refill operation: all normal operations were confirmed.It was unknown whether the alarm sound was cancelled by pressing the reset key when the alarm went off.
Additional Manufacturer Narrative
(b)(4), no iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of unable to refill alarm is not able to be confirmed.According to the event details, the pump passed functional checkout by the distributor after the case.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that an "unable to refill" alarm went off during clinical use with ecmo.After confirming the alarm, the user attempted to press the drive start key but could not.He/she tried to restart the intra-aortic balloon pump (iabp) by nr.Me, but the iabp did not restart.Therefore, the iabp was replaced with a back-up one in the facility.There was no report of patient complications, serious injury or death.The technical engineer of dvx, the distributor, visited to the facility and confirmed operation of the iabp using the simulator set in the eicu equipment room.Leak test, various signal input confirmation, switching operation / drive confirmation, drain / refill operation: all normal operations were confirmed.It was unknown whether the alarm sound was cancelled by pressing the reset key when the alarm went off.Additional information received: there was a report of patient death an unknown amount of time after the reported event.There was no delay in therapy and no alleged device contribution to the patient's death.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12180489
• Report Number: 3010532612-2021-00193
• Device Sequence Number: 4454387
• Product Code: DSP
• UDI-Device Identifier: 30801902043420
• UDI-Public: 30801902043420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: IPN000325
• Device Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1