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

Model Number IPN917285

Device Problem Mechanical Problem (1384)

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

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the pump had high baseline and system error #3 alarms.Pump assembly was replaced".Additional information states the issue "was resolved by the decrease in balloon volume and repositioning the abdomen off the groin site.This did not do anything to the position of the balloon in the aorta.The patient was being supported and no harm to the patient".The current condition to the patient was unknown by the clinical support specialist.If additional information is received, the complaint file will be updated.

Event Description

It was reported that "the pump had high baseline and system error #3 alarms.Pump assembly was replaced".Additional information states the issue "was resolved by the decrease in balloon volume and repositioning the abdomen off the groin site.This did not do anything to the position of the balloon in the aorta.The patient was being supported and no harm to the patient".The current condition to the patient was unknown by the clinical support specialist.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).The reported complaint of "high baseline and system error 3 alarms" is confirmed.The pump alarmed a high baseline (1) during the complaint investigation.A griding noise was noted from the pump assembly consistent with a motor/lead screw malfunction.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the motor/lead screw malfunction.The root cause of this complaint is undetermined.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16409005
• MDR Text Key: 309952433
• Report Number: 3010532612-2023-00117
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN917285
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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