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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2 SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AUTOCAT 2 SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0400
Device Problems Device Alarm System (1012); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of "helium leak" is confirmed based on the returned iab finding. The iab was found with a leak. An external helium leak was confirmed from the iab bifurcate during functional testing. The pump functioned as intended. 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. No further action required. Other remarks: for related complaint see mdr #1219856-2017-00314 and tc #1900056990.
 
Event Description
It was reported that the event occurred on a patient of 173cm in height. The pump alarmed after 4 days use, helium leak. The volume was adjusted, the catheter was moved, the counter pulsation rate was adjusted, and the alarm can't be clear. As a result, the pump and the intra-aortic balloon (iab) were exchange. There were no reported patient deaths or complications to the patient.
 
Manufacturer Narrative
Qn# (b)(4). Other remarks: for related complaint see mdr #1219856-2017-00314 and tc # (b)(4).
 
Event Description
It was reported that the event occurred on a patient of 173cm in height. The pump alarmed after 4 days use, helium leak. The volume was adjusted, the catheter was moved, the counter pulsation rate was adjusted, and the alarm can't be clear. As a result, the pump and the intra-aortic balloon (iab) were exchange. There were no reported patient deaths or complications to the patient.
 
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Brand NameAUTOCAT 2
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 Key7139219
MDR Text Key252102027
Report Number1219856-2017-00338
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0400
Other Device ID Number00801902051721
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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