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

Model Number IPN000320

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the rn that the intra-aortic balloon pump (iabp) had a purge failure 5 alarm and occurred during use on a patient. The clinical support specialist (css) confirmed they had a trigger, helium in the tank, and the iab was connected. Staff stated they had even changed the helium tank prior to calling the hotline "just in case". As a result, the console was successfully exchanged. There was no report of patient complications, serious injury or death.

Event Description

It was reported by the rn that the intra-aortic balloon pump (iabp) had a purge failure 5 alarm and occurred during use on a patient. The clinical support specialist (css) confirmed they had a trigger, helium in the tank, and the iab was connected. Staff stated they had even changed the helium tank prior to calling the hotline "just in case". As a result, the console was successfully exchanged. There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of iabp purge failure alarm is not able to be confirmed. The root cause of the complaint is undetermined. 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. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. The reported complaint will be monitored for any developing trends. No further action required at this time.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9587342
• MDR Text Key: 183176157
• Report Number: 3010532612-2019-00476
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No