Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IAB PUMP; SYSTEM, BALLOON, INTRA-AORTIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL LLC AC3 OPTIMUS IAB PUMP; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN001112
Device Problem Gas/Air Leak (2946)
Patient Problem Insufficient Information (4580)
Event Date 03/07/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
 
Event Description
It was reported that the pump alarmed helium leak during use.As a result, the pcs was replaced.There are no information available on the patient.If additional information is received at a later date the complaint file will be updated.
 
Manufacturer Narrative
(b)(4).No iabp or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of helium loss alarm is not able to be confirmed.The distributor' technician replaced pcs assembly and the issue was resolved.The root cause of the complaint is undetermined.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.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 the pump alarmed helium leak during use.As a result, the pcs was replaced.There are no information available on the patient.If additional information is received at a later date the complaint file will be updated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AC3 OPTIMUS IAB PUMP
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
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key14055430
MDR Text Key289001788
Report Number3010532612-2022-00112
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902084966
UDI-Public30801902084966
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN001112
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
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
-
-