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

Catalog Number IAP-0700

Device Problem Failure to Run on Battery (1466)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that during quality review, "pump only ran on battery for 12 minutes after being charged for 24 hours.Not on patient".

Manufacturer Narrative

Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that during quality review, "pump only ran on battery for 12 minutes after being charged for 24 hours.Not on patient".

Manufacturer Narrative

(b)(4).The reported complaint of "pump only ran on battery for 12 minutes" was not confirmed upon the investigation of the returned sample.The customer returned for investigation was a battery (part number: 4000-9022-001, lot number: 18f22l0006).The sample was returned in a brown cardboard box with protective packaging (inp-1, inp-2).Visual inspection of the battery was performed (inp-3 through inp-8) 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 (anp-2).The iabp gave a proper alarm when disconnected from the ac power (anp-3).Pumping was initiated (anp-4).The unit ran for over 90 minutes along with the proper alarms "less than 20-, 10-, and 5-minutes remaining" (anp-6 through anp-8).The operator manual states "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 s tate." based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nat ure.Other remarks: n/a.Corrected data: n/a.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18111058
• MDR Text Key: 328138045
• Report Number: 3010532612-2023-00638
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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