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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN917285
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2023
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported that "a patient has been on the iabp for 2 days and it had been working well.They had the alarm message that there was a low helium tank.They changed out the tank and they still had the message and the helium gauge said zero.They changed out the tank for another helium tank and had the same issue.They then changed out the pump for a second pump.This pump is working well.Patient is stable and being supported".No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).The reported complaint of "pump had helium leak and purge failure alarms" is not able to be confirmed.No part was returned to teleflex chelmsford for investigation.The field service agent serviced the pump and could not replicate the alarm; however, the helium o-ring was found missing.The field service agent installed a new o-ring and the pump passed functional checkout.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that "a patient has been on the iabp for 2 days and it had been working well.They had the alarm message that there was a low helium tank.They changed out the tank and they still had the message and the helium gauge said zero.They changed out the tank for another helium tank and had the same issue.They then changed out the pump for a second pump.This pump is working well.Patient is stable and being supported".No patient harm or injury.The patient status is reported as "fine".
 
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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 Key16518684
MDR Text Key311519625
Report Number3010532612-2023-00152
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10801902172065
UDI-Public10801902172065
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162820
Number of Events Reported1
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 03/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN917285
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2023
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 Number1
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