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

Model Number IPN917285

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Reported as "excessive buildup of condensation in helium drive line".As reported by a clinical support specialist: "the [clinician] called the hotline to discuss excessive condensation in the helium driveline.She stated there have been no alarms on the pump, it has been pumping without interruption.The condensation is completely clear and is more than a few cc of accumulation.The patient is afebrile.Nsr, condensation bottle emptied, was approximately 2/3 full.Manual purges performed to remove condensation.Discussed possible actions if condensation continues to build up and provided my direct number to call with additional questions.Additional calls to my cell to discuss with cardiology fellow when condensation again accumulated.Manual purge again performed.Central lumen arterial line appears intact, flushes and zeroes without issue, waveform appears normal, no blood present in condensation.I discussed switching out the pump.Eventually, [physician] chose to escalate therapy due to patient's condition, unrelated to iabp therapy and inserted an impella." no report of patient harm or injury.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Additionally no recorder strip was returned for investigation.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "excessive buildup of condensation in helium drive line".As reported by a clinical support specialist: "the [clinician] called the hotline to discuss excessive condensation in the helium driveline.She stated there have been no alarms on the pump, it has been pumping without interruption.The condensation is completely clear and is more than a few cc of accumulation.The patient is afebrile.Nsr, condensation bottle emptied, was approximately 2/3 full.Manual purges performed to remove condensation.Discussed possible actions if condensation continues to build up and provided my direct number to call with additional questions.Additional calls to my cell to discuss with cardiology fellow when condensation again accumulated.Manual purge again performed.Central lumen arterial line appears intact, flushes and zeroes without issue, waveform appears normal, no blood present in condensation.I discussed switching out the pump.Eventually, [physician] chose to escalate therapy due to patient's condition, unrelated to iabp therapy and inserted an impella." no report of patient harm or injury.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16107053
• MDR Text Key: 308669535
• Report Number: 3010532612-2023-00011
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2023
• 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
• Treatment: N/A.; N/A.
• Patient Sex: Male