• 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 INC. AC3 OPTIMUS IABP NA/EMEA 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 INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN001112
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
It was reported that after the intra-aortic balloon (iab) was inserted, pumping initiated and the intra-aortic balloon pump (iabp) had a purge failure alarm. The staff attempted to reset and restart the iabp multiple times but no change. As a result, the iabp was exchanged and the second iabp pumped without issue. There was no report of patient complications, serious injury or death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAC3 OPTIMUS IABP NA/EMEA
Type of DeviceSYSTEM, 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
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key10530942
MDR Text Key206834253
Report Number3010532612-2020-00251
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902084966
UDI-Public30801902084966
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN001112
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
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 Unkown

-
-