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

Catalog Number IAP-0700

Device Problem Communication or Transmission Problem (2896)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

It was reported "difficulty with pressure readings on the ac3".Additional information received stated that "the staff could not get the pump to stop printing even though they had pressed the printer icon to off".The pump was swtiched for a second ac3.There was no report of patient complications, serious injury or death.Patient condition reported as "critical" as it was reported that pump was used in support for open heart surgery; no change to patient regarding the pump change.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "difficulty with pressure readings on the ac3".Additional information received stated that "the staff could not get the pump to stop printing even though they had pressed the printer icon to off".The pump was swtiched for a second ac3.There was no report of patient complications, serious injury or death.Patient condition reported as "critical" as it was reported that pump was used in support for open heart surgery; no change to patient regarding the pump change.

Manufacturer Narrative

Qn#(b)(4).The reported complaint of "staff could not get the pump to stop printing" is not able to be confirmed.The product or recorder strip was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.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/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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15310362
• MDR Text Key: 305505278
• Report Number: 3010532612-2022-00336
• Device Sequence Number: 1
• Product Code: DSP
• 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
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: IAB CATHETER; IAB CATHETER
• Patient Sex: Male