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

Catalog Number IAP-0500

Device Problem Device Alarm System (1012)

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

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a field service report l700379 that the intra-aortic balloon pump (iabp) while using on a patient had helium loss and high pressure alarms that would not stop.The field service engineer (fsr) performed functional checks, leak checks and all were okay.There were no patient complications, reported.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "helium loss and high pressure alarm" is not confirmed.The pump was checked by the field service agent 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 lot number/serial number 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 action required at this time.

Event Description

It was reported via a field service report l700379 that the intra-aortic balloon pump (iabp) while using on a patient had helium loss and high pressure alarms that would not stop.The field service engineer (fsr) performed functional checks, leak checks and all were okay.There were no patient complications, reported.

• 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: 7145462
• MDR Text Key: 95828533
• Report Number: 1219856-2017-00327
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

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-0500
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA 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