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

Model Number	IPN917285
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem 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".
Additional Manufacturer Narrative
(b)(4).
Additional 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 or Problem 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
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17225513
• Report Number: 3010532612-2023-00354
• Device Sequence Number: 17908306
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• 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): 06/03/2023

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/24/2023
• 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
• Patient Sex: Female