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

Model Number IPN917285

Device Problem Communication or Transmission Problem (2896)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

It was reported that after the patient had been on the pump for 45 days, the pump started "making audible clicking noise when pumping with changes to bpw".Troubleshooting included 2 manual purges and emptying of the condensation bottle which resolved the problem but only for approximately 15-20 seconds, then the clicking resumed.As a result, the pump was exchanged for another pump.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The reported complaint of "changes to bpw" was not able to be confirmed as the iabp part was not returned for investigation.According to the attached service report, the issue was not able to be duplicated; however, the augmentation valve was replaced.A device history record (dhr) review was conducted for the lot number with no relevant findings.Based on dhr review, the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

Event Description

It was reported that after the patient had been on the pump for 45 days, the pump started "making audible clicking noise when pumping with changes to bpw".Troubleshooting included 2 manual purges and emptying of the condensation bottle which resolved the problem but only for approximately 15-20 seconds, then the clicking resumed.As a result, the pump was exchanged for another pump.No patient harm or injury.The patient status is reported as "fine".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17215961
• MDR Text Key: 318022063
• Report Number: 3010532612-2023-00347
• 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: K162820
• 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: 06/01/2023

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: IPN917285
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 07/25/2023
• 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
• Patient Sex: Male