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  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "strange bpw in 1:1 without alarms".Additionally it was reported "[the user] stated there was no evidence of blood in the tubing, all of the connections were tight,no kinks, and no ectopy.[the user] also stated a leak test was done and it passed.Also [the user] changed the helium tank.[the user also] disconnected and reconnected the transducer cable.This did not resolve the issue.[the pump was] exchanged and the second console hadthe exact same issue." it was also reported that "the patient did not sustain injury or expire".The patient's current condition is reported as "critical".See associated mdrs #3010532612-2024-00259, mdr #3010532612-2024-00258.

Manufacturer Narrative

Qn# (b)(4).The actual device was not returned; however, the customer provided photos for evaluation.The photos show the pump triggering normally in a 1:2 ratio, and the balloon pressure waveform (bpw) baseline dropped below zero 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 bpw abnormal is confirmed based on the pictures provided in the complaint.The pictures show the balloon p ressure baseline dropped below zero 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 balloon pressure dropped below zero.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 Description

It was reported "strange bpw in 1:1 without alarms".Additionally it was reported "[the user] stated there was no evidence of blood in the tubing, all of the connections were tight,no kinks, and no ectopy.[the user] also stated a leak test was done and it passed.Also [the user] changed the helium tank.[the user also] disconnected and reconnected the transducer cable.This did not resolve the issue.[the pump was] exchanged and the second console had the exact same issue." it was also reported that "the patient did not sustain injury or expire".The patient's current condition is reported as "critical".See associated mdrs #3010532612-2024-00259.Mdr #3010532612-2024-00258.

• 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: 19075834
• MDR Text Key: 339894150
• Report Number: 3010532612-2024-00257
• 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 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