MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT 2; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000302

Device Problems Device Alarm System (1012); Mechanical Problem (1384); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that "during use, the system error 3 alarm, the drive board is poorly connected, and the engineer replaces the drive board".Additional information received stated that the pump was changed.No patient harm, injury, or consequence reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint of system error 3 alarm is not able to be confirmed.The product was not returned for investigation.According to the additional information received, the m-force motor driver was replaced.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

Event Description

It was reported that "during use, the system error 3 alarm, the drive board is poorly connected, and the engineer replaces the drive board".Additional information received stated that the pump was changed.No patient harm, injury, or consequence reported.Patient condition reported as "fine".

• Brand Name: AUTOCAT 2
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15266894
• MDR Text Key: 305247885
• Report Number: 3010532612-2022-00317
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

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 Model Number: IPN000302
• Device Catalogue Number: IAP-0400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 09/16/2022
• 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
• Treatment: NONE REPORTED; NONE REPORTED