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

Model Number	IPN000320
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
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 when checking the pump before use, "the battery won't hold a charge".No patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).Returned for investigation was a battery.The positive battery terminal was noted bent and external damage was noted on the lower body of the battery.No other damage was noted.The battery was installed into a known good ac3 for functional testing.The iabp powered up successfully.With no alarm, all voltages were present (+5v, +12v and -12v) and within specifications.The battery load test was performed.The iabp was run on battery until the iabp shut down.The battery was then left to charge in the iabp for over 9 hours.The full charge of battery was 12.9 volts.The iabp shut off at immediately after disconnected from ac power.The battery failed the load test.Note: per operator's manual "the battery should be maintained at full charge whenever possible.Arrow international recommends that the iabp must be kept plugged into a proper ac receptacle whenever possible including time when the unit is in storage or not in use.The power indicator will illuminate when ac power is present.The batteries should not be stored in a discharged state." a device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of "the battery won't hold a charge" is confirmed.During the investigation, the returned battery failed the battery load test.Upon visual inspection, external damage was also noted to the battery.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the short battery run time.A definitive root cause could not be determined but a potential cause of the short battery life is a result of battery maintenance.No further action required at this time.This 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.
Event or Problem Description
It was reported that when checking the pump before use, "the battery won't hold a charge".No patient involvement.

• Brand Name: AUTOCAT2 WAVE
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18497863
• Report Number: 3010532612-2024-00020
• Device Sequence Number: 15464985
• Product Code: DSP
• UDI-Device Identifier: 30801902092183
• UDI-Public: 30801902092183
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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: IPN000320
• Device Catalogue Number: IAP-0500F
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown