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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ARROW SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000254
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 05/31/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a teleflex sales rep. (sr) as told by (b)(6) (hospital staff) "placed on (b)(6) 2021 at 1915 on (b)(6) 1856 helium loss while moving the patient no blood in tubing. On (b)(6) 2021 at 2123 had trigger loss alarm and flushed the side port and it resolved. On (b)(6) 2021 at 8:07 helium loss 2 alarm with no blood in the tubing the nurse restarted the pump and saw the blood immediately in the tubing, clamped the tubing, and turned off pump. Intra-aortic balloon (iab) was removed 8:21 from ccu attending showing signs of stroke. " there was no alleged contribution of the device malfunction to the reported stroke.
 
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Brand NameARROW
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 Key12078846
MDR Text Key258895353
Report Number3010532612-2021-00167
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
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 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F21D0040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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