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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 Problems Pumping Stopped (1503); Gas Leak (2946); Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
Continuation of n milrinone. (b)(4). See mdr #3010532612-2019-00455 and tc #(b)(4), mdr #3010532612-2019-00435 and tc #(b)(4) for complaint involving the same patient and event.
 
Event Description
It was reported by the rn that the intra-aortic balloon pump (iabp) had stop pumping and the alarm was, purge failure. The rn called the hotline and reported to the clinical support specialist (css) that the pump alarmed for purge failure. There is both electrocardiogram (ecg) and arterial pressure (ap) waveform on the pump. The gas driveline tubing was secure and there is adequate helium in the tank. The staff reset the alarm and the pump started pumping again. Again, the purge failure alarm occurred. As a result, the pump was powered off and back on. The pump is now pumping without alarming. This took less than 5 seconds and the patient was stable throughout. There was no report of patient injury or consequence.
 
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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 Key9530153
MDR Text Key185019448
Report Number3010532612-2019-00457
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 12/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
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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