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

Catalog Number IAP-0500

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the rn who called to discuss an issue with the pump using excessive amounts of helium.They had a full tank last night, and within 4 hours half of the tank was gone, this occurred multiple times they have replaced the tank and about every 4 hours half of the tank is gone.They have checked the washer in the yoke, it was found to be intact.There is no audible loss of gas.There were no gas loss alarms or any other alarms on the pump.The connections are intact.As a result, the pump was exchanged and the new pump has not been losing gas.Patient outcome: the patient is supported on pump and achieving the goals of therapy.No complications to the patient were reported.There was no delay or interruption in therapy that caused no harm to the patient.

Manufacturer Narrative

Qn#: (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "pump using excessive amounts of helium" is not confirmed.The pump was checked by the customer and no problem was found with the pump.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the serial and lot numbers with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.No further required at this time.

Event Description

It was reported by the rn who called to discuss an issue with the pump using excessive amounts of helium.They had a full tank last night, and within 4 hours half of the tank was gone, this occurred multiple times they have replaced the tank and about every 4 hours half of the tank is gone.They have checked the washer in the yoke, it was found to be intact.There is no audible loss of gas.There were no gas loss alarms or any other alarms on the pump.The connections are intact.As a result, the pump was exchanged and the new pump has not been losing gas.Patient outcome: the patient is supported on pump and achieving the goals of therapy.No complications to the patient were reported.There was no delay or interruption in therapy that caused no harm to the patient.

• 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: 7138526
• MDR Text Key: 95612868
• Report Number: 1219856-2017-00309
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• 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: Unknown
• Patient Sequence Number: 1