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 Consequences Or Impact To Patient (2199)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that when the intra-aortic balloon pump (iabp) was in use on a patient, the staff experienced a helium loss alarm (3).As a result, the iabp was replaced.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
Qn#(b)(4).No iap part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of the helium loss 3 alarm is not able to be confirmed.If the part or additional information is received at a later date, a full investigation will be performed.The root cause of the complaint is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that when the intra-aortic balloon pump (iabp) was in use on a patient, the staff experienced a helium loss alarm (3).As a result, the iabp was replaced.There was no report of patient complications, serious injury or death.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11124590
• Report Number: 3010532612-2020-00396
• Device Sequence Number: 13610819
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 12/16/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1