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

Catalog Number	IAP-0700
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on patient(s), "3 of their 6 pumps have shut off, could be battery problem or battery's not be charged".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.See associated mdrs #3010532612-2023-00440 and 3010532612-2023-00442.
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on patient(s), "3 of their 6 pumps have shut off, could be battery problem or battery's not be charged".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.Associated mdrs #3010532612-2023-00440 and 3010532612-2023-00442.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "pumps have shut off" was confirmed based upon the sample received.The customer returned a battery (part number: 4000-9022-002, lot number: 18f22f0062) for investigation.The sample was returned in a white cardboard shipping box with protective packaging (inp-1 through inp-2).Visual inspection of the battery was performed (inp-3 through inp-7) and no abnormality 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 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 70 minutes when running on battery power (anp-5).The iabp alarmed "less than 10 minutes remaining" after approximately 79 minutes when running on battery power (anp-6).The iabp alarmed "less than 5 minutes remaining" after approximately 85 minutes when running on battery power (anp-7).The total battery runtime was approximately 97 minutes (anp-8).The pump passed the battery load test.The operator's manual states "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." 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 is not performed per the iabp operating instructions manual, the battery may 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.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Additional information received on 23 aug 2023 states that the 3 events of the pumps shutting down occurred on 3 different patients.The issue was resolved by switching out the pumps for another.No patient harm or injury.The current status of the patients is reported as "no longer on the pump".

• 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: 17510071
• Report Number: 3010532612-2023-00441
• Device Sequence Number: 7956676
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/25/2023

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/31/2023
• 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