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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
Catalog Number IAP-0500
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the nurse that the helium tank on the intra-aortic balloon pump (iabp) had to be changed twice, but the helium gauge still reads red. The rn reported it had been fine through the night and the pump has continued to pump with no interruptions or issues. The clinical support specialist (css) had the nurse attempt another tank with the same result. The nurse then got another pump, turn it on and the helium tank registered blue, almost full. The nurse took the tank from that pump and put it on the current pump and the tank registered red, almost empty. As a result, the pump was exchange without difficulty and will be sent to biomed. There was no report of patient complications, serious injury or death.
 
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Brand NameAUTOCAT2 WAVE
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 Key9459605
MDR Text Key183767443
Report Number3010532612-2019-00441
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
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 11/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
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 Received01/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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