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

Model Number	IPN917285
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported from the biomedical engineering department that a pump was brought down with a "note that states that the iabp did not register any ap pressures on the display when it was in use".Further information states that "ap works in fos, transducer, and monitor modes.Performed pm, no problems found.Unit checks out ok".No patient harm or injury.The customer is unable to answer our requests for additional information regarding the patient's current status or how the issue was resolved.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of "iabp doesn't register any ap pressures on the display when in use" was not able to be confirmed as no iabp part or recorder strip was returned for investigation.The pump was checked by a field service agent and could not replicate the issue.The pump passed functional checkout.Based on a review of the device history record (dhr), the product met specification upon release.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.
Event or Problem Description
It was reported from the biomedical engineering department that a pump was brought down with a "note that states that the iabp did not register any ap pressures on the display when it was in use".Further information states that "ap works in fos, transducer, and monitor modes.Performed pm, no problems found.Unit checks out ok".No patient harm or injury.The customer is unable to answer our requests for additional information regarding the patient's current status or how the issue was resolved.If further information is received, the complaint file will be updated.

• 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: 17263267
• Report Number: 3010532612-2023-00373
• Device Sequence Number: 14930223
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 06/12/2023

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: 06/12/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/03/2023
• 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