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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2 SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AUTOCAT 2 SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0400
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
It was reported that the machine automatically shuts down many times during use. After removing the catheter, it was discontinued. There was no report of patient complications, serious injury or death. After repeated testing by the simulator for 4 hours, the pump was returned to service.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameAUTOCAT 2
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
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key13026745
MDR Text Key282970095
Report Number3010532612-2021-00393
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902051721
UDI-Public00801902051721
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0400
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
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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