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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problems Loose or Intermittent Connection (1371); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). For related complaint involving the same patient see mdr #3010532612-2019-00165 and (b)(4), mdr #3010532612-2019-00192 and (b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) alarmed for multiple helium loss alarms on two separate pumps. The rn switched out the pump but they were still getting helium loss alarms so the clinical specialist had the registered nurse disconnect and reconnect the connections on the catheter to ensure it was tight. There was no more alarms after that. There was no report of patient complications serious injury or death.
 
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Brand NameULTRAFLEX IAB: 7.5FR 40CC
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 Key8663543
MDR Text Key146829023
Report Number3010532612-2019-00166
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K000729
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 05/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Catalogue NumberIAB-06840-U
Device Lot Number18F18C0032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2018
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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