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

Model Number	IPN917285
Medical Device Problem Codes	Device Alarm System (1012); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medwatch report #mw5117820.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported via a medwatch report.The report states, "iabp alarming.The alarm was "ekg trigger loss".The balloon was not inflating with each complex.A-line pressures stable.The iabp was on "autopilot" and ekg was showing up on screen.The iabp started alarming "high pressure" and was erratically inflating and deflating.All lines rechecked again from the patient to the pump.Noted nothing wrong.The helium line then flooded with blood.Patient was send to the operating room to replace the balloon".Complaint received from fda medwatch voluntary report.The reporter elected to not be identified, and teleflex is unable to request additional information.No further complaint or customer details are available.
Event or Problem Description
Reported via a medwatch report.The report states, "iabp alarming.The alarm was "ekg trigger loss".The balloon was not inflating with each complex.A-line pressures stable.The iabp was on "autopilot" and ekg was showing up on screen.The iabp started alarming "high pressure" and was erratically inflating and deflating.All lines rechecked again from the patient to the pump.Noted nothing wrong.The helium line then flooded with blood.Patient was send to the operating room to replace the balloon".Complaint received from fda medwatch voluntary report.The reporter elected to not be identified, and teleflex is unable to request additional information.No further complaint or customer details are available.
Additional Manufacturer Narrative
(b)(4).The reported complaint of multiple alarms was not able to be confirmed as the product was not returned for investigation.A device history record (dhr) review was unable to be completed as no lot number/serial number was reported.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.

• 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: 17225284
• Report Number: 3010532612-2023-00352
• Device Sequence Number: 7082727
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/02/2023

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: 06/02/2023
• 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: Unknown