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

Model Number	IPN917285
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the pump had constant helium loss alarms when on a patient.As a result, the pump was swapped out for another.No patient harm or injury.The patient status is reported as fine.
Event or Problem Description
It was reported that the pump had constant helium loss alarms when on a patient.As a result, the pump was swapped out for another.No patient harm or injury.The patient status is reported as fine.
Additional Manufacturer Narrative
Qn # (b)(4).No iabp part was returned for investigation.The customer provided a photo which shows an iv pole placed in the iabp.According to the field service report received, a non-teleflex iv pole with a different diameter was used by the customer and the augmentation valve fitting was loosened.The issue was resolved by re-tightening the fitting.A device history record (dhr) review was conducted for the lot number reported with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of constant helium loss alarms was confirmed by the field service engineer.According to the field service report, a non-teleflex iv pole with a different diameter was used and the augmentation valve fitting was loosened.The issue was resolved by retightening the augmentation valve fitting.The product was not 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 loosened fitting.The most probable root cause is customer handling.No further action required at this time.This 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17059822
• Report Number: 3010532612-2023-00309
• Device Sequence Number: 20094928
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/17/2023

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: 05/17/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/10/2023
• 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