MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAP-0700
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "pump lost power during patient transport." as a result, the pump was switched out for another.No patient harm or injury.
Event or Problem Description
It was reported that "pump lost power during patient transport." as a result, the pump was switched out for another.No patient harm or injury.
Additional Manufacturer Narrative
Qn# (b)(4).Additional information received on 02aug2023 reported that there was condensation build-up in the balloon and the pump.The reported complaint of "pump lost power" was confirmed based on the inspection of the returned sample.The customer returned a battery (part number: 4000-9022-002, lot number: 18c20f0063) for investigation.Visual inspection of the battery was performed (inp-1 through inp-5) and no abnormality was noted.The returned battery failed the battery load test.During the complaint investigation, the pump operated on battery power for approximately a total of 46 minutes after a full charge.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 running on battery until the iabp shut down.The batteries were then left to charge in the iabp for over 9 hours.The full charge of batteries was 13.1 volts (anp-2).Pumping was initiated (anp-3).The iabp gave a proper alarm when disconnected from the ac power (anp-4).The iabp alarmed "less than 20 minutes remaining" after approximately 40 minutes when running on battery power (anp-5).The iabp alarmed "less than 10 minutes remaining" after approximately 44 minutes when running on battery power (anp-6).Within 1 minute of the 10 minutes remaining alarm, the pump alarmed "less than 5 minutes remaining" and shut down before a picture could be taken of the alarm.The total battery runtime was approximately 46 minutes (anp-7).Additionally, 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.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet test specifications 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 was a result of maintaining of the battery.No further action was required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• 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: 17437807
• Report Number: 3010532612-2023-00459
• Device Sequence Number: 8979009
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• 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): 07/17/2023

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 Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown