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

Model Number	IPN000302
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
While in use on a patient, the report states that "the machine stopped operating suddenly and could not be restarted to work normal.After that, the doctor decided to remove the catheter.The patient's condition did not deteriorate significantly after the withdrawal of the machine and the patient's family decided to give up the treatment and discharged the patient from the hospital.The engineer check, the main issue is system failure due to aging of valve set components".Further information states that after the patient was discharged, the patient died at home.The hospital did not have information regarding the date and time of death.The reported cause of death is heart failure.Due to patient privacy, the hospital was not able to disclose the patient's medical history or underlying medical conditions.Additional information states that when the stop operating, it stopped pumping and completely shut off.It also states that the pump was plugged into a wall outlet when this event occurred.The customer is unable to provide the pump log file.
Additional 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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
While in use on a patient, the report states that "the machine stopped operating suddenly and could not be restarted to work normal.After that, the doctor decided to remove the catheter.The patient's condition did not deteriorate significantly after the withdrawal of the machine and the patient's family decided to give up the treatment and discharged the patient from the hospital.The engineer check, the main issue is system failure due to aging of valve set components".Further information states that after the patient was discharged, the patient died at home.The hospital did not have information regarding the date and time of death.The reported cause of death is heart failure.Due to patient privacy, the hospital was not able to disclose the patient's medical history or underlying medical conditions.Additional information states that when the stop operating, it stopped pumping and completely shut off.It also states that the pump was plugged into a wall outlet when this event occurred.The customer is unable to provide the pump log file.

• Brand Name: AUTOCAT 2
• Common Device Name: 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: 16371610
• Report Number: 3010532612-2023-00052
• Device Sequence Number: 6813836
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Age: 65 YR
• Patient Sex: Female