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

Catalog Number	IAP-0500
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "[the user] called the hotline to discuss that the pump was found to be in the off position with no alarms noted.There are no alarm strips.She stated upon entering the patient's room the pump was found to be in the off position, power was still on.She resumed pumping without issue but wanted to discuss how long the pump had been down and the potential for clot formation.[the user] stated that as best as she can tell based on the monitor information and the ap waveform, the pump was off for just under 20 minutes the patient remained stable throughout.I discussed the time limit for iabc dormancy in the ifu and suggested she discuss this with the md.She also stated she would like to switch the pump just in case and send it to biomed, although it is currently pumping without issue.Second call to the hotline to assist with exchanging the pump at 0329 est".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "pump stopped pumping without alarms" is not able to be confirmed.No part or recorder strip was returned for investigation.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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "[the user] called the hotline to discuss that the pump was found to be in the off position with no alarms noted.There are no alarm strips.She stated upon entering the patient's room the pump was found to be in the off position, power was still on.She resumed pumping without issue but wanted to discuss how long the pump had been down and the potential for clot formation.[the user] stated that as best as she can tell based on the monitor information and the ap waveform, the pump was off for just under 20 minutes the patient remained stable throughout.I discussed the time limit for iabc dormancy in the ifu and suggested she discuss this with the md.She also stated she would like to switch the pump just in case and send it to biomed, although it is currently pumping without issue.Second call to the hotline to assist with exchanging the pump at 0329 est".No patient harm or injury.The patient status is reported as "fine".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18185977
• Report Number: 3010532612-2023-00677
• Device Sequence Number: 20642434
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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-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: 11/15/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/05/2024
• 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