MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0700

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2024

Event Type  malfunction  

Event Description

It was reported " no aug on ap waveform and strange bpw in 1:1 without alarms".Additionally it was reported " [the console was] switched to operator mode and ap trigger.Issue resolved.[the user tried] to disconnect the ecg cable and put pump back into auto.The issue returned immediately.Switched back to operator and it resolved.In autopilot and 1:2 it worked, but the patient needs 1:1 support." it was decided to continue using this same pump console to complete therapy due to patient needs.It was also stated that " the patient did not sustain injury or expire".Patient's current condition is reported as "critical".Please see associated mdrs: #3010532612-2024-00259 & #3010532612-2024-00257.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "no aug on ap waveform and strange bpw in 1:1 without alarms".Additionally it was reported " [the console was] switched to operator mode and ap trigger.Issue resolved.[the user tried] to disconnect the ecg cable and put pump back into auto.The issue returned immediately.Switched back to operator and it resolved.In autopilot and 1:2 it worked, but the patient needs 1:1 support." it was decided to continue using this same pump console to complete therapy due to patient needs.It was also stated that " the patient did not sustain injury or expire".Patient's current condition is reported as "critical".Please see associated mdrs: #3010532612-2024-00259 and #3010532612-2024-00257.

Manufacturer Narrative

Qn# (b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.The photo shows the ap waveform abnormal which is consistent with the event details.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.The reported complaint of ap waveform abnormal is confirmed based on the picture provided in the complaint.The picture shows the ap waveform abnormal which is consistent with the event details.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; however, the specifications were not met during the complaint investigation due to the abnormal ap waveform.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.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: 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: 19075839
• MDR Text Key: 339894382
• Report Number: 3010532612-2024-00258
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female