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

Catalog Number	IAP-0701
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " the monitor heart rate was 40 - 50, the iabp heart rate was 100 - 140, the ap pressure monitor was 115/40 (63), and the iabp showed 77/38 (58).The data is not synchronized, heart rate, ap values are too different.This state has persisted.Manually cutting to ap triggers counter pulsation, which basically synchronizes.However, in auto mode, the machine will select ecg trigger, the data is not synchronized, heart rate, ap values are too different".Additional information states that the pump console was replaced to continue therapy.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).No iabp part was returned for investigation.The customer provided videos for evaluation.The first video shows the ap pressure monitor at 115/40 (68) and the heart rate was at 45, and the other video shows artifacts on the arterial pressure waveform and ap triggers counter pulsation resulting in a high heart rate 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 triggering difficulty is confirmed based on the videos provided in the complaint.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 or Problem Description
It was reported " the monitor heart rate was 40 - 50, the iabp heart rate was 100 - 140, the ap pressure monitor was 115/40 (63), and the iabp showed 77/38 (58).The data is not synchronized, heart rate, ap values are too different.This state has persisted.Manually cutting to ap triggers counter pulsation, which basically synchronizes.However, in auto mode, the machine will select ecg trigger, the data is not synchronized, heart rate, ap values are too different".Additional information states that the pump console was replaced to continue therapy.No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: AC3 OPTIMUS IABP NA/AJLA
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19336772
• Report Number: 3010532612-2024-00361
• Device Sequence Number: 2607615
• Product Code: DSP
• UDI-Device Identifier: 30801902091254
• UDI-Public: 30801902091254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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 Catalogue Number: IAP-0701
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown