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

Model Number IPN917285

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 04/10/2023

Event Type  malfunction  

Event Description

It was reported that "pump had purge failure alarms while on patient.Pump switched out quickly with no patient complications." additional information states, "patient therapy was resumed with no harm to patient".

Manufacturer Narrative

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

Event Description

It was reported that "pump had purge failure alarms while on patient.Pump switched out quickly with no patient complications." additional information states, "patient therapy was resumed with no harm to patient".

Manufacturer Narrative

(b)(4).Returned for investigation was a pcs assembly.A visual inspection of the pcs assembly was performed and no abnormality was noted.All valves were individually tested by powering them on and off using an external power supply, and all valves functioned as intended.The pcs assembly was installed into a known good lab inventory ac3 for functional testing.The pump was powered on, and pumping was initiated.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 51 minutes (2 drain cycles) 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 reported complaint of "purge failure alarm" is not confirmed.The returned pcs assembly passed visual and functional test specifications during complaint investigation.Based on a review of the dhr, the product met specification upon release.No further action required at this time.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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16768584
• MDR Text Key: 313733471
• Report Number: 3010532612-2023-00216
• 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: K060309
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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: 05/30/2023
• 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