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 02/22/2023

Event Type  malfunction  

Event Description

It was reported that the pump is alarming for "high baseline".The patient is not moving, the balloon does appear to be in the correct position, and they have already tried repositioning the patient.Staff stated that the pump will immediately alarm for high baseline when they try to restart.As a result, the pump had to be exchanged for another.The patient remained stable throughout the incident with no complications reported.No harm or injury to the patient.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the pump is alarming for "high baseline".The patient is not moving, the balloon does appear to be in the correct position, and they have already tried repositioning the patient.Staff stated that the pump will immediately alarm for high baseline when they try to restart.As a result, the pump had to be exchanged for another.The patient remained stable throughout the incident with no complications reported.No harm or injury to the patient.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).Returned for investigation was an ac3 pump assembly (p/n: 33-3200-001, s/n: (b)(6)).Visual inspection of the pump assembly was performed and noted that one of the pins on the connector j2 came loose.No other abnormality was noted.The pump assembly with a loose j2 connector pin was installed into a known good lab inventory ac3 for functional testing.The pump was powered up successfully.The pump alarmed purge failure upon initiated pumping.Pumping was reinitiated with the same result.The loose pin was then put back into its position.Pumping was initiated; the pump pumped fine without any alarms.The purge cycle was performed multiple times with no alarms or errors.The leak test was performed and passed both source side and patient side.The pump was then left to run for over 2 hours and no alarms or errors occurred.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 risk is acceptable.This will be monitored for any developing trends.The reported complaint of "high baseline alarm" is confirmed.A loose connector j2 pin was noted upon receiving of the part, which most likely caused the reported alarm.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 loose connector j2 pin.The root cause is undetermined.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
• 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: 16439173
• MDR Text Key: 310352811
• Report Number: 3010532612-2023-00136
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2023
• 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