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

Model Number IPN001112

Device Problem Mechanical Problem (1384)

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

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.

Event Description

It was reported by the clinical support specialist (css) that the pump had 2 system error 3 alarms.It was noted that the pump restarted both times without issue.As a result, the pump was swapped, and the reported pump was sent to biomed.There was no report of patient complications, serious injury, or death.

Event Description

It was reported by the clinical support specialist (css) that the pump had 2 system error 3 alarms.It was noted that the pump restarted both times without issue.As a result, the pump was swapped, and the reported pump was sent to biomed.There was no report of patient complications, serious injury, or death.

Manufacturer Narrative

(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of system error 3 is not able to be confirmed.According to the field service report, the pump assembly was replaced by the hospital's biomed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

Manufacturer Narrative

Qn# (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 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 successfully.After approximately 30 minutes of pumping, a grinding noise was noted coming from the pump assembly.After a total of 6 hours of pumping, a system error 3 alarm occurred.Each valve of the pcs assembly was connected to a 12v dc power supply to check proper function.Each valve responded properly to the 12v supplied with an audible click, indicating proper valve function with no stuck valves.The top of the pump assembly's bellows box was opened, and pumping was initiated to more closely determine source of the grinding noise.It was noted the grinding sound appeared to be coming from the lead screw which drives the bellows.No closer inspection to what was causing the grinding sound could be completed.Note: this is the original pump assembly for this pump.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of system error 3 alarm is confirmed.The pump alarmed system error 3 during the complaint investigation.A grinding noise was heard coming from the lead screw within the pump assembly.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 system error 3 alarm.The root cause of this complaint is manufacturing related.This will be monitored for any developing trends.

Event Description

It was reported by the clinical support specialist (css) that the pump had 2 system error 3 alarms.It was noted that the pump restarted both times without issue.As a result, the pump was swapped, and the reported pump was sent to biomed.There was no report of patient complications, serious injury, or death.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville, MA 27560
• MDR Report Key: 13723602
• MDR Text Key: 287347206
• Report Number: 3010532612-2022-00046
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2022

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
• Device Operator: Health Professional
• Device Model Number: IPN001112
• 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?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 03/30/2022; 02/06/2023
• Supplement Dates FDA Received: 04/04/2022; 02/07/2023
• 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