MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT2; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0435

Device Problems Failure to Run on Battery (1466); Pumping Stopped (1503)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via field service report l700100.The pump shut off during transport.After switching to our balloon pump on the way out of the hospital, the balloon alarmed battery 20 minutes left (it had been plugged in charging in the truck and during transition of care at the bedside) then the screen flashed white and the balloon stopped pumping.Several attempts were made to restart the balloon unsuccessfully.Returned to cath lab.The balloon was plugged in and it worked.Waited for a pump from night ground unit.Switched to night ground units pump successfully and completed transport without issue.There were no patient complications reported.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "pump shut down on battery power" is not confirmed.The returned battery passed visual and functional test specifications.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.The root cause of the complaint is undetermined.No further action required.

Event Description

It was reported via field service report l700100.The pump shut off during transport.After switching to our balloon pump on the way out of the hospital, the balloon alarmed battery 20 minutes left (it had been plugged in charging in the truck and during transition of care at the bedside) then the screen flashed white and the balloon stopped pumping.Several attempts were made to restart the balloon unsuccessfully.Returned to cath lab.The balloon was plugged in and it worked.Waited for a pump from night ground unit.Switched to night ground units pump successfully and completed transport without issue.There were no patient complications reported.

• Brand Name: AEROAUTOCAT2
• Type of Device: SYSTEM, 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 Key: 7241097
• MDR Text Key: 99313313
• Report Number: 1219856-2018-00017
• 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: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0435
• Other Device ID Number: 00801902051745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 03/10/2018
• 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: Unknown
• Patient Sequence Number: 1