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

Model Number IPN001112

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there were multiple purge failure alarms while on patient.As a result, another pump was used.There was no report of patient complications, serious injury or death.The field service agent (fsa) ran the pump on test equipment and the customer's equipment but could not duplicate symptoms.The fsa replaced the cpm and the pcs as a precaution.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "multiple purge failure alarms" is not confirmed.The returned pcs assembly and cpm board passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot numbers with 4 relevant findings.However, the affected pcs assemblies were sent back to the vendor and reworked.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

Event Description

It was reported that there were multiple purge failure alarms while on patient.As a result, another pump was used.There was no report of patient complications, serious injury or death.The field service agent (fsa) ran the pump on test equipment and the customer's equipment but could not duplicate symptoms.The fsa replaced the cpm and the pcs as a precaution.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 13152084
• MDR Text Key: 283154042
• Report Number: 3010532612-2022-00001
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• 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
• Treatment: NI.; NI.