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

Model Number IPN000320

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that prior to use on a patient, during start up of the pump, the user received an alarm.The device was stopped.After the doctor's follow-up observation, it was used normally.There was no report of patient complications, serious injury or death.

Event Description

It was reported that prior to use on a patient, during start up of the pump, the user received an alarm.The device was stopped.After the doctor's follow-up observation, it was used normally.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of "when the device starts up, there is an alarm and it cannot continue to be used" is not able to be confirmed.According to the additional information received, the cpm board was replaced and the issue was resolved.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the serial number/lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

• 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: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 13059564
• MDR Text Key: 282610327
• Report Number: 3010532612-2021-00420
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/12/2022
• 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