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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the registered nurse (rn), when the intra-aortic balloon pump (iabp) was in use, the staff noted that the touchscreen does not respond. The rn stated that "the pump is pumping, but the on/off says off and the hard key is red. " she also, explains that nothing happens when she uses the touchscreen. The clinical care specialist (css) advice the rn to power on and off the pump a couple of times but nothing happened. As a result, the css recommended to switch out the pump. The rn was able to swap out for another pump. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of "touchscreen unresponsive" was confirmed by the field service agent; however, the returned display head passed visual and functional test specifications during the investigation. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. A nonconformance has been initiated to further investigate the root cause.
 
Event Description
It was reported by the registered nurse (rn), when the intra-aortic balloon pump (iabp) was in use, the staff noted that the touchscreen does not respond. The rn stated that "the pump is pumping, but the on/off says off and the hard key is red. " she also, explains that nothing happens when she uses the touchscreen. The clinical care specialist (css) advice the rn to power on and off the pump a couple of times but nothing happened. As a result, the css recommended to switch out the pump. The rn was able to swap out for another pump. There was no report of patient complication or serious injury and 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 Key7806855
MDR Text Key117962850
Report Number3010532612-2018-00259
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 07/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2018
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 Manufacturer08/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2018
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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