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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, "pump only ran on battery for approx.20 minutes with a full charge".Additional information received states that there was no harm to the patient.The issue was resolved by exchanging the pump for another pump.There is no further information of the current status of the patient.

Manufacturer Narrative

Qn# (b)(4).The reported complaint of "pump only ran on battery for approximately 20 minutes with a full charge" was confirmed upon investigation of the returned sample.The customer returned a battery (part number: 4000-9022-001, lot number: 18f22g0039) for investigation.The sample was returned in a brown cardboard box with protective shipping packaging (inp-1, inp-2).Visual inspection of the battery was performed (inp-3 through inp-12) 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 iabp alarmed "less than 20 minutes remaining" after approximately 19 minutes when running on battery power (anp-5).Within 1 minute of the 20 minutes remaining alarm, the pump alarmed "less than 10 minutes remaini ng" and the iabp shut off at immediately after the alarms were cleared (anp-6).The total battery runtime was approximately 19 minutes.The operator's manual states "the battery should be maintained at full charge whenever possible.Arrow international recommends that the ac3 iabp 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." 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 maintaining of the battery.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that during use on a patient, "pump only ran on battery for approx.20 minutes with a full charge".Additional information received states that there was no harm to the patient.The issue was resolved by exchanging the pump for another pump.There is no further information of the current status of the patient.

• 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: 18502880
• MDR Text Key: 333209906
• Report Number: 3010532612-2024-00052
• 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,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 02/05/2024
• 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