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

Catalog Number	IAP-0500
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported " bio-med received a call of pump shutting off, (believe lost power) been running in bio-med without problems but would like pump checked out." additional information states "checked voltages and battery-checked power switch and reset connections on switch.Tapped around switch (newest style switch) shake tested, could not even get screen to flicker.Preformed functional checks pass all.Pump had been left turned on in bio-med and and no problem seen." the pump was replaced with another pump to continue therapy.Patient's current condition is unknown.No patient harm or injury reported.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "pump shutting off" is not able to be confirmed.No part was returned to teleflex chelmsford for investigation.According to the service report, the field service engineer checked the pump and could not replicate the problem.The pump passed functional checkout.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported " bio-med received a call of pump shutting off, (believe lost power) been running in bio-med without problems but would like pump checked out." additional information states "checked voltages and battery-checked power switch and reset connections on switch.Tapped around switch (newest style switch) shake tested, could not even get screen to flicker.Preformed functional checks pass all.Pump had been left turned on in bio-med and no problem seen." the pump was replaced with another pump to continue therapy.Patient's current condition is unknown.No patient harm or injury reported.

• Brand Name: AUTOCAT2 WAVE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18970928
• Report Number: 3010532612-2024-00249
• Device Sequence Number: 20457503
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown