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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0700
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)
Event Date 02/22/2019
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4). For related events on the same patient see mdr #3010532612-2019-00061 and tc # (b)(4), mdr #3010532612-2019-00062 and tc # (b)(4), mdr #3010532612-2019-00063 and tc# (b)(4).
 
Event Description
It was reported by the registered nurse (rn) that the, touchscreen of the intra-aortic balloon pump (iabp) was frozen. The clinical support specialist (css) had the rn verify that the touchscreen was unlocked, and the staff attempted to lock and unlock multiple times with no change. The hard keys are still functioning, and the pump is pumping without interruption. The css had the rn change the ratio, use the cursor, the hard keys are working but no change is reflected on the screen. The rn power reset the pump with no change in frozen screen. As a result, the pump was swapped out for another. There was a report of patient death. The rn reported that the patient had an ejection fraction of 12% and was not a surgical candidate. The device did not cause or contribute to the patient's death.
 
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Brand NameAC3 OPTIMUS IABP NA/EMEA
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 Key8428796
MDR Text Key139081755
Report Number3010532612-2019-00085
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162820
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 02/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
Was Device Evaluated by Manufacturer? Yes
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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