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

Catalog Number	CARDIAC UNKNOWN
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch " the iabp was alarming for helium loss detected.The patient was redirected and repositioned in bed when the bedside rn notied blood in the helium line.The iabp was immediately turned off and the line was clamped.Cardiology blue was notified and came straight to bedside.The patient initially denied any chest pain or shortness of breath, and vital signs were stable.Cardiac and vascular surgery were also called to bedside and the patient was taken to the operating room due to iabp rupture".
Additional Manufacturer Narrative
(b)(4).Medwatch#: mw5153630.
Additional Manufacturer Narrative
(b)(4).Medwatch#: mw5153630 the reported complaint of "blood in the helium line" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.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 via medwatch " the iabp was alarming for helium loss detected.The patient was redirected and repositioned in bed when the bedside rn notied blood in the helium line.The iabp was immediately turned off and the line was clamped.Cardiology blue was notified and came straight to bedside.The patient initially denied any chest pain or shortnes of breath, and vitial signs were stable.Cardiac and vascular surgery were also called to bedside and the patient was taken to the operating room due to iabp rupture".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19353745
• Report Number: 3010532612-2024-00365
• Device Sequence Number: 12639789
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CARDIAC UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/12/2024
• 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