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

Catalog Number IAP-0700

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2024

Event Type  malfunction  

Event Description

It was reported " decreased battery life.The pump shut off after bring unplugged.The pump also indicated a full charge while plugge in.Power wass eventually restored and the pump came back on with the original settings".The patient's current condition is "unknown".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) additional information received 16-apr-2024 indicates there was no harm to the patient, no medical intervention was required, and that "the patient was supported during the entire event".It was also reported that "when they unplugged the pump from power it alarmed low battery, they plugged it back in power was restored but due to patient ambulating they exchanged for a pump that was fully charged." returned for investigation was a battery.Visual inspection of the battery was performed 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 battery was then left to charge in the iabp for over 9 hours.The full charge of battery was 12.9 volts.The iabp gave a proper alarm when disconnected from the ac power.Pumping was initiated.The iabp alarmed the "less than 20, 10, 5 minutes remaining" after approximately 31 minutes when running on battery power, and the iabp shut off at immediately after the alarms were cleared.The pump failed the battery load test.Note: per operator's manual "the battery should be maintained at full charge whenever possible.Arrow international recommends that the ac3 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 "decreased battery life" is confirmed.The returned battery failed the battery load test.During the complaint investigation, the pump shut off after approximately 37 minutes when operating on battery power after a full charge.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 Description

It was reported "decreased battery life.The pump shut off after bring unplugged.The pump also indicated a full charge while plugger in.Power was eventually restored and the pump came back on with the original settings".

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19081991
• MDR Text Key: 339893548
• Report Number: 3010532612-2024-00264
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAP-0700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1