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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 Failure to Zero (1683)
Patient Problem No Information (3190)
Event Date 02/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This would not be likely to cause or contribute to a death or serious injury, and if it were to reoccur, it would be unlikely to cause or contribute to a death or serious injury. A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury. The fos is a portion of the catheter that monitors the patient's arterial pressure. When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen. Iab therapy continues to the patient uninterrupted.
 
Event Description
It was reported that prior to use on a patient, the staff noted that the intra-aortic balloon pump (ibap) had a failed fos. The staff stated that when the cal key was inserted, they got the yellow on the checklist but no audible tones. The staff then got another iabp and got the same results. The staff then got another intra-aortic balloon (iab) and same results occurred with the first iabp (no audible tones), on the second iabp the staff did get the double tones and zeroed appropriately. No information was provided regarding patient condition.
 
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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
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key11416670
MDR Text Key240371527
Report Number3010532612-2021-00064
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 02/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2021
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 Manufacturer02/25/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2021
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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