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

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.

• Brand Name: AEROAUTOCAT2
• Type of Device: INTRA-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 Key: 6250577
• MDR Text Key: 64778038
• Report Number: 1219856-2016-00299
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• 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 Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0435
• Other Device ID Number: 30801902051746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/08/2017
• 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