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

Catalog Number	IAP-0400
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reported as "drain failure alarms x3 unresolved with troubleshooting".The report states that the user called "regarding 2 purge failure alarms.He endorsed there was no excessive condensation in the driveline, drain bottle had 1-2 cc and was emptied, and denied blood in the driveline.He verified the connections to the arrow iab and did not note any visible kinks or correlation with ectopy.During the alarms, he had no changes to his ecg or ap waveforms with the iabp in autopilot.He endorsed the helium as 'nearly full' with the knob in the helium compartment fully open.He verified there was no condensation buildup in the driveline.Manual purge x2 attempted.On facetime, a third and fourth 'drain failure' alarm issued.No ectopy at this time and patients hr 90-100.I asked if the patient was tachycardic for all alarms and he stated the first alarm occurred with the hr 85-90 bpm.Ecg and ap waveforms appropriate with trigger acceptance noted.Drain bottle empty and no visible kinks to driveline or external drain tubing.Patient lying flat and still when alarms issues with no indication of a kink in the bpw.I assisted him in moving connections to the second iabp, which resolved alarm." no patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
Reported as "drain failure alarms x3 unresolved with troubleshooting".The report states that the user called "regarding 2 purge failure alarms.He endorsed there was no excessive condensation in the driveline, drain bottle had 1-2 cc and was emptied, and denied blood in the driveline.He verified the connections to the arrow iab and did not note any visible kinks or correlation with ectopy.During the alarms, he had no changes to his ecg or ap waveforms with the iabp in autopilot.He endorsed the helium as 'nearly full' with the knob in the helium compartment fully open.He verified there was no condensation buildup in the driveline.Manual purge x2 attempted.On facetime, a third and fourth 'drain failure' alarm issued.No ectopy at this time and patients hr 90-100.I asked if the patient was tachycardic for all alarms and he stated the first alarm occurred with the hr 85-90 bpm.Ecg and ap waveforms appropriate with trigger acceptance noted.Drain bottle empty and no visible kinks to driveline or external drain tubing.Patient lying flat and still when alarms issues with no indication of a kink in the bpw.I assisted him in moving connections to the second iabp, which resolved alarm." no patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of drain and purge failure alarms is not able to be confirmed.No part was returned to teleflex chelmsford 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.

• 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: 17836079
• Report Number: 3010532612-2023-00561
• Device Sequence Number: 7667085
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/17/2023

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-0400
• 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: 09/17/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown