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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 Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2022
Event Type  malfunction  
Event Description
It was reported by the clinical support specialist (css) that the pump was alarming "on battery. " the staff pressed the reset key and still had the alarm. The pump was pumping and supporting the patient. The staff tried changing the power cord; however, it did not resolve the issue. As a result, the staff changed the console, and the reported pump was sent to biomed. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). There is an investigation ongoing into this reported complaint. A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
 
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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
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key13710358
MDR Text Key286919779
Report Number3010532612-2022-00049
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902051715
UDI-Public30801902051715
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2022
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
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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