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 INC. AUTOCAT2 WAVE; 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. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500
Device Problems Gas/Air Leak (2946); Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) was not reading the helium.The field service engineer (fse) tried two new helium tanks with no improvement.As a result, the pump was switched out and sent to bio med.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The report complaint of system unable to read helium pressure was confirmed by the field service engineer; however, the returned helium regulator assembly and helium adaptor passed functional test specifications during complaint investigation.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.No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) was not reading the helium.The field service engineer (fse) tried two new helium tanks with no improvement.As a result, the pump was switched out and sent to bio med.There was no report of patient complications, serious injury or death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AUTOCAT2 WAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8955326
MDR Text Key156309207
Report Number3010532612-2019-00310
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2019
Date Manufacturer Received10/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-