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

Model Number	IPN000324
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
There was no patient involvement.It was reported that during preventive maintenance, the service engineer detected a purge failure.As a result, the pcs was replaced and the intra-aortic balloon pump (iabp) was placed back into service.
Event or Problem Description
There was no patient involvement.It was reported that during preventive maintenance, the service engineer detected a purge failure.As a result, the pcs was replaced and the intra-aortic balloon pump (iabp) was placed back into service.
Additional Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "purge failure alarm" is confirmed.The release spring inside the vent valve was found stuck which was the result of the alarm.The root cause of how the release spring became stuck 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.

• Brand Name: AUTOCAT2 WAVE ITALIAN
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11230155
• Report Number: 3010532612-2021-00024
• Device Sequence Number: 14479183
• Product Code: DSP
• UDI-Device Identifier: 30801902092190
• UDI-Public: 30801902092190
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/28/2020

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: IPN000324
• Device Catalogue Number: IAP-0500I
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1