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

Model Number	IPN000302
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The report states that "the patient was admitted at 02:50 on (b)(6) 2022.The white screen appeared about 20 to 30 minutes after the normal implantation.The white screen lasted about 20 to 30 minutes.The engineer checked the interface, and then restart the pump, it can work normally.The patient died at 06:30 on (b)(6) 2022." additional information states that the physician does not believe that the pump contributed to the patient's death.After the pump displayed a white screen, the pump was ultimately swapped out for a non-teleflex pump, then the patient expired.The underlying disease of the patient's condition was heart disease.Per the customer, the hospital did not provide the cause of death.No autopsy was performed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The report states that "the patient was admitted at 02:50 on october 29, 2022.The white screen appeared about 20 to 30 minutes after the normal implantation.The white screen lasted about 20 to 30 minutes.The engineer checked the interface, and then restart the pump, it can work normally.The patient died at 06:30 on (b)(6) 2022." additional information states that the physician does not believe that the pump contributed to the patient's death.After the pump displayed a white screen, the pump was ultimately swapped out for a non-teleflex pump, then the patient expired.The underlying disease of the patient's condition was heart disease.Per the customer, the hospital did not provide the cause of death.No autopsy was performed.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "white screen" is not able to be confirmed.No part was returned for investigation.According to the event detail, the issue was resolved after rebooting the powerbased 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.Other remarks: n/a.Corrected data: n/a.

• 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: 16150426
• Report Number: 3010532612-2023-00024
• Device Sequence Number: 7051808
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 01/04/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 56 KG