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

Model Number IPN917285

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the pump had a system error 3 subcode 1 alarm during training.There is no report of patient involvement.As a result, the pump assembly was replaced.

Manufacturer Narrative

(b)(4).Returned for investigation was an ac3 pump assembly (p/n: 33-3200-001, s/n: (b)(6)).The part was returned in a pump assembly shipping box with protective shipping packaging.Visual inspection of the sample was performed, and no abnormality was noted.The returned pump assembly was installed into a known good ac3 for functional testing.The pump was powered up successfully, and no abnormalities were noted on the screen.Pumping was initiated; however, the motor was heard continuously turning and then the pump alarmed "system error 3 (1)".The pump assembly was removed from the lab inventory ac3 and the top outer housing of the pump assembly's bellows box was opened to further investigate.The washer that connects to the bellows plate was noted to be misplaced.Upon initiation of pumping, the leadscrew spins continuously without engaging the bellows.Note: this is the original pump assembly for this pump.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of system error 3 is confirmed.The pump alarmed system error 3 during the complaint investigation.The leadscrew was found disengaged from the bellows.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the disengagement of the leadscrew to the bellows.The most probable root cause is manufacturing related.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the pump had a system error 3 subcode 1 alarm during training.There is no report of patient involvement.As a result, the pump assembly was replaced.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16529385
• MDR Text Key: 311377435
• Report Number: 3010532612-2023-00156
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN917285
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1