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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AEROAUTOCAT 2 WAVE SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0535
Device Problems Low Battery (2584); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/03/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not received the device for investigation therefore the reported complaint of "the pump stop pumping" is not able to be confirmed. The field service engineer checked the pump and could not replicate the problem. The root cause of the reported complaint is undetermined. If the parts are returned at a later date, a full investigation will be completed. 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. This complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that during ground transporting the patient to a hospital, the screen began to flash on and off, and the pump then s topped "augmenting". The pump stopped pumping in use, but did not power down. The transport team then powered the pump off and then back on. The displayed came back on as usual, and was displaying all the normal parameters. When they attempted to resume pumping, the screen again started to flash on and off, and the pump would not resume pumping. The patient was switched to the receiving facilities pump and then resumed as usual. The patient was stable with no complications.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during ground transporting the patient to a hospital, the screen began to flash on and off, and the pump then s topped "augmenting". The pump stopped pumping in use, but did not power down. The transport team then powered the pump off and then back on. The displayed came back on as usual, and was displaying all the normal parameters. When they attempted to resume pumping, the screen again started to flash on and off, and the pump would not resume pumping. The patient was switched to the receiving facilities pump and then resumed as usual. The patient was stable with no complications.
 
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Brand NameAEROAUTOCAT 2 WAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6855975
MDR Text Key246663995
Report Number1219856-2017-00193
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 08/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0535
Other Device ID Number00801902051738
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 Received10/04/2017
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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