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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT2 INTRA-AORTIC BALLOON PUMP

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ARROW INTERNATIONAL INC. AEROAUTOCAT2 INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0435
Device Problems Display or Visual Feedback Problem (1184); Connection Problem (2900)
Patient Problem No Information (3190)
Event Date 12/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a field service report: (b)(4). Symptom: controller system failure. Pump stays at 2. 5cc volume. Findings/action taken: screen white. Replaced display head could not duplicate original symptom. Checked all cables and connectors. Unit checks ok. Fcn level: 1416, software level: 2. 24, op
=
on patient, unconfirmed.
 
Manufacturer Narrative
Qn#(b)(4). The reported complaint is unable to be confirmed by the field service engineer. The "2. 5cc balloon volume" could not be reproduced, therefore the root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the iabp serial/ lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex will continue to monitor for any trends.
 
Event Description
It was reported via a field service report: l611483. Symptom: controller system failure. Pump stays at 2. 5cc volume. Findings/action taken: screen white. Replaced display head could not duplicate original symptom. Checked all cables and connectors. Unit checks ok. Fcn level: 1416, software level: 2. 24. Op
=
on patient. Unconfirmed.
 
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Brand NameAEROAUTOCAT2
Type of DeviceINTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
3015 carrington mill blvd
morrisville, PA 27560
6104783117
MDR Report Key6250577
MDR Text Key64778038
Report Number1219856-2016-00299
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 Paramedic
Type of Report Initial,Followup
Report Date 12/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0435
Other Device ID Number30801902051746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2017
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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