• 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. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC 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. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Fluid Leak (1250); Off-Label Use (1494); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The rn reported receiving helium loss alarms from the intra-aortic balloon pump (iabp). A call was placed to the clinical support specialist (css) by the rn who stated that the alarms began when the tubing accidentally got disconnected from the pump. She stated that there is no blood noted in the tubing and the alarm has not recurred in 30 minutes. When checked, the quick connect and the o-ring were in tact with no cracks. The rn reconnected and began pumping within 20 seconds. Patient remained stable during the pause. The css did a follow-up call and spoke with the rn who is caring for the patient. The rn relayed that the intra-aortic balloon (iab) was not pulled over night, but there was a flash of blood in the driveline that happened yesterday. The iab was emergently removed without incidence. The patient is stable without therapy, so they opted to not reinsert yesterday. The patient is going to have a swan ganz catheter placed today and will go for a planned iab insertion tomorrow. There was no report of patient injury or consequence. The iab was inserted off label via axillary insertion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key9452774
MDR Text Key183766335
Report Number3010532612-2019-00435
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
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 11/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F18K0012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-