MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 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 02/26/2022

Event Type  malfunction  

Event Description

It was reported by the field service representative (fsr) that the staff received a purge failure (3) alarm when the pump started up.As a result, the staff used another pump.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.After the case, the fsr found a purge failure (3) alarm while on the patient simulator.The fsr replaced the pneumatic control system (pcs), and the pump passed all functional checks.

Manufacturer Narrative

(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of purge failure is confirmed.The returned pcs assembly's balloon pressure transducer was faulty, which could cause a purge failure alarm.The root cause of this complaint is undetermined.Corrections have been established for this issue as a result of an nc (non-conformance) and this device was manufactured prior to the release of those corrections.A device history record (dhr) review was conducted for the lot numbers with 5 relevant findings; however, the affected pcs assemblies were returned to the vendor.

Event Description

It was reported by the field service representative (fsr) that the staff received a purge failure (3) alarm when the pump started up.As a result, the staff used another pump.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.After the case, the fsr found a purge failure (3) alarm while on the patient simulator.The fsr replaced the pneumatic control system (pcs), and the pump passed all functional checks.

• Brand Name: AUTOCAT2 WAVE
• 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: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 13929700
• MDR Text Key: 288039853
• Report Number: 3010532612-2022-00101
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• 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: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: NI.; NI.