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

Model Number	IPN000328
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
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 during preventative maintenance, the pump failed the battery load test.No patient involvement.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "battery failing the battery load test" was confirmed by the field service engineer.The product was not returned for investigation.Iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance, and storage of the batteries.If battery maintenance was not performed per the iabp operating instructions manual, the battery might not provide the expected minimum run time of operating power.An examination of the device history record (dhr) could not be completed because the dhr information was unavailable, but the service history information was reviewed for the reported complaint and no problems were identified during the review of the service history for this device.According to the service report, the battery was sent to and replaced by the hospital's biomed.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported that during preventative maintenance, the pump failed the battery load test.No patient involvement.

• Brand Name: AUTOCAT2 WAVE REFURBISHED
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17215630
• Report Number: 3010532612-2023-00343
• Device Sequence Number: 3022173
• Product Code: DSP
• UDI-Device Identifier: 30801902093913
• UDI-Public: 30801902093913
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: IPN000328
• Device Catalogue Number: IAP-0500X
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/24/2023
• 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
• Patient Sex: Unknown