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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000320
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the rn that the intra-aortic balloon pump (iabp) had a purge failure 5 alarm and occurred during use on a patient. The clinical support specialist (css) confirmed they had a trigger, helium in the tank, and the iab was connected. Staff stated they had even changed the helium tank prior to calling the hotline "just in case". As a result, the console was successfully exchanged. There was no report of patient complications, serious injury or death.
 
Event Description
It was reported by the rn that the intra-aortic balloon pump (iabp) had a purge failure 5 alarm and occurred during use on a patient. The clinical support specialist (css) confirmed they had a trigger, helium in the tank, and the iab was connected. Staff stated they had even changed the helium tank prior to calling the hotline "just in case". As a result, the console was successfully exchanged. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of iabp purge failure alarm is not able to be confirmed. 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 risks. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
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Brand NameAUTOCAT2 WAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9587342
MDR Text Key183176157
Report Number3010532612-2019-00476
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 12/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000320
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No

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