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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500
Device Problem Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2017
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of "pump using excessive amounts of helium" is not confirmed. The pump was checked by the customer and no problem was found with the pump. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the serial and lot numbers with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint will be monitored for any developing trends. No further required at this time.
 
Event Description
It was reported by the rn who called to discuss an issue with the pump using excessive amounts of helium. They had a full tank last night, and within 4 hours half of the tank was gone, this occurred multiple times they have replaced the tank and about every 4 hours half of the tank is gone. They have checked the washer in the yoke, it was found to be intact. There is no audible loss of gas. There were no gas loss alarms or any other alarms on the pump. The connections are intact. As a result, the pump was exchanged and the new pump has not been losing gas. Patient outcome: the patient is supported on pump and achieving the goals of therapy. No complications to the patient were reported. There was no delay or interruption in therapy that caused no harm to the patient.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the rn who called to discuss an issue with the pump using excessive amounts of helium. They had a full tank last night, and within 4 hours half of the tank was gone, this occurred multiple times they have replaced the tank and about every 4 hours half of the tank is gone. They have checked the washer in the yoke, it was found to be intact. There is no audible loss of gas. There were no gas loss alarms or any other alarms on the pump. The connections are intact. As a result, the pump was exchanged and the new pump has not been losing gas. Patient outcome: the patient is supported on pump and achieving the goals of therapy. No complications to the patient were reported. There was no delay or interruption in therapy that caused no harm to the patient.
 
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Brand NameAUTOCAT2 WAVE
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 Key7138526
MDR Text Key250252324
Report Number1219856-2017-00309
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
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 11/26/2017
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-0500
Other Device ID Number00801902051714
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 Received01/24/2018
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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