MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/AJLA

Catalog Number IAP-0701

Device Problem Mechanical Problem (1384)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(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 that prior to use, the machine reported a fault "baseline too high" and could not work normally.

Manufacturer Narrative

(b)(4).The reported complaint of "high baseline alarm" is not able to be confirmed.No part or recorder strip was returned to teleflex chelmsford for investigation.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 root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

Event Description

It was reported that prior to use, the machine reported a fault "baseline too high" and could not work normally.

• Brand Name: AC3 OPTIMUS IABP NA/AJLA
• 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, MA 27560
• MDR Report Key: 14619393
• MDR Text Key: 301504882
• Report Number: 3010532612-2022-00232
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902051714
• UDI-Public: 00801902051714
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

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-0701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 07/05/2022
• 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