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

Catalog Number IAP-0700

Device Problem Defective Device (2588)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported "frequent helium loss alarms and strange bpw".Additionally it was reported that the bpw is below baseline and "plat eau" is sloped high.The user also previously exchanged the pump and nothing changed.The pump was meeting the goals of therapy and alarms decreased.Therefore, it was not discontinued or changed.No patient injury or consequence reported.The patient's current condition reported as "critical".Associated mdr #: 3010532612-2024-00144.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "frequent helium loss alarms and strange bpw".Additionally it was reported that the bpw is below baseline and "plat eau" is sloped high.The user also previously exchanged the pump and nothing changed.The pump was meeting the goals of therapy and alarms decreased.Therefore, it was not discontinued or changed.No patient injury or consequence reported.The patient's current condition reported as "critical".Associated mdr #: 3010532612-2024-00144.

Manufacturer Narrative

(b)(4).Upon review of the complaint information it was discovered that the initial report, submitted on 20-feb-2024, is a duplicate of mdr# 3010532612-2024-00144; therefore, this report should be retracted.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18743603
• MDR Text Key: 336300807
• Report Number: 3010532612-2024-00142
• 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: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• 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: 30CC FIBEROPTIC CATHETER; 30CC FIBEROPTIC CATHETER
• Patient Sex: Female
• Patient Race: Native Hawaiian Or Other Pacific Islander