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

Model Number	IPN917285
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "iabp has shut off a couple times while on a patient.The registered nurse rn was able to restart the iabp by switching the on/off switch off,then back on.The whole console was shutting down with no warning.This morning we swapped out the console with a new one so we could bring the affected unit to ce.There didn't seem to be any instigating factor causing the iabp to shut down." additional information received states that there was no impact, harm or injury to the patient.The patient status is reported as "received a heart transplant the next day and is no longer on iabp support".
Additional Manufacturer Narrative
(b)(4).Returned for investigation were a martek power supply (p/n: 77-0063-003, s/n: 0590-1519) and a battery (p/n: 4000-9022-001, l/n: 18f23a0001).The samples were returned in a brown cardboard box with protective shipping packaging.Visual inspection of the power supply and battery was performed and no abnormality was noted.The battery and power supply were 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 batteries were then left to charge in the iabp for over 9 hours.The full charge of batteries was 13.1 volts.Pumping was initiated.The iabp gave a proper alarm when disconnected from the ac power.The iabp alarmed "less than 20 minutes remaining" after approximately 59 minutes when running on battery power.The iabp alarmed "less than 10 minutes remaining" after approximately 81 minutes when running on battery power.The iabp alarmed "less than 5 minutes remaining" after approximately 91 minutes when running on battery power.The total battery runtime was approximately 113 minutes.The pump passed the battery load test.The iabp was then plugged into ac power to simulate an endurance test.The iabp was left running for over 24 hours with no alarms or errors.Note: per operator's manual "the battery should be maintained at full charge whenever possible.Arrow international recommends that the ac2 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 numbers with 4 relevant findings; however, the affected power supplies were returned to the vendor.The reported complaint of the pump shut off while on a patient is not confirmed.The returned battery and power supply passed visual and functional test specifications.The device history record (dhr) was reviewed with 4 relevant findings; however, the affected power supplies were returned to the vendor.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "iabp has shut off a couple times while on a patient.[the rn] was able to restart the iabp by switching the on/off switch off, then back on.The whole console was shutting down with no warning.This morning we swapped out the console with a new one so we could bring the affected unit to ce.There didn't seem to be any instigating factor causing the iabp to shut down." additional information received states that there was no impact, harm or injury to the patient.The patient status is reported as "received a heart transplant the next day and is no longer on iabp support".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17240192
• Report Number: 3010532612-2023-00364
• Device Sequence Number: 17850222
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/06/2023

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: IPN917285
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/04/2023
• 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
• Patient Sex: Unknown