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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); Battery Problem (2885); Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the staff experienced multiple alarms on the intra-aortic balloon pump (iabp) that would not resolve. The patient was previously supported and achieving the goals of therapy. The first alarm was a "battery malfunction" alarm followed by a system error 8 alarm and the pump stopped pumping. The alarm was reset, and restart attempted with immediate purge failure alarm. Several restarts attempted with system error 7, 8 and purge failure alarms. The pump is plugged into ac power, both power and battery indicator are lit. Battery breaker is on (appropriate). Ecg trigger accepted; helium psi good. Power reset attempted with no change. As a result, the iabp was exchanged with minimal delay or issue. 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
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key10515207
MDR Text Key206349604
Report Number3010532612-2020-00246
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 08/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2020
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2020
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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