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

Model Number	IPN000302
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).N/a, other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the battery failed battery load test in accordance with service manual (voltage lower than 11.8 v after 60 min) during preventative maintenance.The faulty battery has been previously replaced in 2021 (b)(6) 2021).The battery has been replaced.The machine was returned to service.Faulty battery not available (disposed by hospital)".No report of patient involvement.
Event or Problem Description
It was reported that "the battery failed battery load test in accordance with service manual (voltage lower than 11.8 v after 60 min) during preventative maintenance.The faulty battery has been previously replaced in 2021 (10.05.2021).The battery has been replaced.The machine was returned to service.Faulty battery not available (disposed by hospital)".No report of patient involvement.
Additional Manufacturer Narrative
(b)(4).The reported complaint of the "short battery run time" is not able to be confirmed.No part has returned to teleflex chelmsford for investigation.According to expedited quality review (eqr) report, the battery was replaced, and the pump was returned to service.Based 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.Iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance and storage of the batteries.If battery maintenance is not performed per the iabp operating instructions manual, the battery may not provide the expected minimum run time of operating power.

• 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: 15746365
• Report Number: 3010532612-2022-00505
• Device Sequence Number: 5660752
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/23/2022

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: 10/23/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/12/2022
• 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
• Patient Sex: Unknown