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

Catalog Number	IAP-0500J
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
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) pump was in use, the staff experienced a helium loss alarm.The user also noted that the helium gas in the tank was decreasing quickly.As a result, the pump was replaced by a back-up.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation.The reported complaint of helium loss alarm is not able to be confirmed.A teleflex field service agent serviced the pump and could not duplicate the alarm, and no leaks were noted.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 risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
Event or Problem Description
It was reported that when the intra-aortic balloon pump (iabp) pump was in use, the staff experienced a helium loss alarm.The user also noted that the helium gas in the tank was decreasing quickly.As a result, the pump was replaced by a back-up.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8488674
• Report Number: 3010532612-2019-00087
• Device Sequence Number: 19324278
• Product Code: DSP
• UDI-Device Identifier: 00801902092199
• UDI-Public: 00801902092199
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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 Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1