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

Model Number IPN917285

Device Problem Communication or Transmission Problem (2896)

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

Event Date 06/02/2023

Event Type  malfunction  

Event Description

Reported as "systolic values and diastolic values reading as same number".The patient was a transfer from an outside facility with a clotted central lumen on a competitor iab.Alternate arterial access obtained and transduced.Troubleshooting included repositioning the patient, verifying the transducer signal and connections, rebooting iabp screen, power cycling the pump, and adjusting the timing.None of these measures resolved the issue.As a result, the pump was switched out for a different pump.The 2nd pump was manually timed with only minimal improvement.Iab volume reduction attempted with no improvement.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The reported complaint of "systolic values and diastolic values reading as same number" was confirmed based on the customer supplied pictures.The attached pictures show the diastolic and systolic pressures matching and improvement after troubleshooting.No iabp part was returned 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 incorrect hemodynamics.The root cause of the complaint was 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 Description

Reported as "systolic values and diastolic values reading as same number".The patient was a transfer from an outside facility with a clotted central lumen on a competitor iab.Alternate arterial access obtained and transduced.Troubleshooting included repositioning the patient, verifying the transducer signal and connections, rebooting iabp screen, power cycling the pump, and adjusting the timing.None of these measures resolved the issue.As a result, the pump was switched out for a different pump.The 2nd pump was manually timed with only minimal improvement.Iab volume reduction attempted with no improvement.No patient harm or injury.The patient status is reported as "fine".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17225513
• MDR Text Key: 318119874
• Report Number: 3010532612-2023-00354
• 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: 06/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2023
• 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