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

Model Number IPN000320

Device Problems Pumping Stopped (1503); Gas Leak (2946); Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Continuation of n milrinone. (b)(4). See mdr #3010532612-2019-00455 and tc #(b)(4), mdr #3010532612-2019-00435 and tc #(b)(4) for complaint involving the same patient and event.

Event Description

It was reported by the rn that the intra-aortic balloon pump (iabp) had stop pumping and the alarm was, purge failure. The rn called the hotline and reported to the clinical support specialist (css) that the pump alarmed for purge failure. There is both electrocardiogram (ecg) and arterial pressure (ap) waveform on the pump. The gas driveline tubing was secure and there is adequate helium in the tank. The staff reset the alarm and the pump started pumping again. Again, the purge failure alarm occurred. As a result, the pump was powered off and back on. The pump is now pumping without alarming. This took less than 5 seconds and the patient was stable throughout. There was no report of patient injury or consequence.

• Brand Name: AUTOCAT2 WAVE
• 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: 9530153
• MDR Text Key: 185019448
• Report Number: 3010532612-2019-00457
• 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

• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/30/2019
• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/23/2020
• 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