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

Model Number	IPN001113
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the ac3 displays an error 3 alarm when the user turns on the ac3 power switch.As a result, the pump assembly was replaced and the pump worked normally".No patient involvement reported.
Event or Problem Description
It was reported that "the ac3 displays an error 3 alarm when the user turns on the ac3 power switch.As a result, the pump assembly was replaced and the pump worked normally".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "system error 3" is confirmed.The sample was returned for investigation.Returned for investigation was an ac3 pump assembly.The sample was returned in a brown cardboard box with protective shipping packaging.Visual inspection of the pump assembly was performed and no abnormality for noted.Two customer photos were submitted and reviewed during the investigation.The pictures show the pump assembly, and the iabp issuing a system error 3 alarm.The pump assembly was installed into a known good lab inventory ac3 for functional testing.The pump was successfully powered up.A rattling noise was noted from the pump assembly and the pump alarmed system error 3 immediately upon startup.The top of the pump assembly's bellows box was opened, and pumping was initiated to more closely determine the rattling noise noted.It was noted the rattling sound appeared to be coming from the stepping motor which drives the bellows.A closer inspection was performed into what was causing the stepping motor to rattle and it was noted that the system was unable to find a home position and kept on turning until the alarm triggered.A quick experiment was performed by pressing lightly on the home sense while pumping was initiated.The system was then able to find its home position and pumping was continued.No loose hardware was noted.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet test specifications during the complaint investigation due to the communication failure (unable to find home).The root cause of the complaint is undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.

• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15310482
• Report Number: 3010532612-2022-00331
• Device Sequence Number: 14102101
• Product Code: DSP
• UDI-Device Identifier: 30801902091254
• UDI-Public: 30801902091254
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: IPN001113
• Device Catalogue Number: IAP-0701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown