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

Model Number IPN000302

Device Problem Mechanical Problem (1384)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that the patient suffered a cardiac arrest on (b)(6) 2022 and was placed on ecmo.On (b)(6) 2023 an iab was inserted.The iabp alarmed "system error 3" 6-10 times every day.The medical staff restarted the iabp in an attempt to fix the alarm.On (b)(6) 2023, the iabp was swapped out.There is no report of patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient suffered a cardiac arrest on (b)(6) 2022 and was placed on ecmo.On (b)(6) 2023 an iab was inserted.The iabp alarmed "system error 3" 6-10 times every day.The medical staff restarted the iabp in an attempt to fix the alarm.On (b)(6) 2023, the iabp was swapped out.There is no report of patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Additionally no recorder strip was returned for investigation.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16403948
• MDR Text Key: 309952007
• Report Number: 3010532612-2023-00110
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

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 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: 02/09/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 03/31/2023
• 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
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 67 KG