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

Model Number	IPN000325
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
There was no patient involvement.It was reported that during operational checking of the intra-aortic balloon pump (iabp) (battery- operated) at the distributor's site, after about 60 minutes, a "large helium leak" alarm and "high base line" alarm occurred.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "high baseline and helium loss alarm" is not confirmed.The returned m-force motor driver assembly passed visual and functional test specifications.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 revised risk.This will be monitored for any developing trends.
Event or Problem Description
There was no patient involvement.It was reported that during operational checking of the intra-aortic balloon pump (iabp) (battery- operated) at the distributor's site, after about 60 minutes, a "large helium leak" alarm and "high base line" alarm occurred.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11706599
• Report Number: 3010532612-2021-00099
• Device Sequence Number: 11736151
• 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): 03/31/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1