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. AC3 OPTIMUS IABP NA/AJLA; 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/AJLA; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0701
Device Problems Loose or Intermittent Connection (1371); Failure to Read Input Signal (1581)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the fos catheter was inserted into patient and the intra-aortic balloon pump (iabp) started, it was noted that the helium and battery icon both had crosses on them.No ecg, ap, and balloon waveform detected on the iabp.As a result, the pump was swapped out.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.When the engineering team check the equipment, it was noted that the communication cable connection between front end board and cpm board was loose and its "hook" that was supposed to secure the connection was not securing it.The pump was working fine after all connections was secured.
 
Event Description
It was reported that when the fos catheter was inserted into patient and the intra-aortic balloon pump (iabp) started, it was noted that the helium and battery icon both had crosses on them.No ecg, ap, and balloon waveform detected on the iabp.As a result, the pump was swapped out.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.When the engineering team check the equipment, it was noted that the communication cable connection between front end board and cpm board was loose and its "hook" that was supposed to secure the connection was not securing it.The pump was working fine after all connections was secured.
 
Manufacturer Narrative
(b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of red x's on helium and battery icons and no patient signals is confirmed.A field service technician serviced the pump and found a loose cable connection between the cpm and feb boards, which is the suspected cause of the complaint.The root cause of this complaint is undetermined.A device history record (dhr) review was conducted for the lot 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 revived risk.This will be monitored for any developing trends.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AC3 OPTIMUS IABP NA/AJLA
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9104362
MDR Text Key182373123
Report Number3010532612-2019-00340
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0701
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-