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

Model Number IPN917285

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that "at 1032, patient's iabp console began to alarm 'loss of signal'.Upon assessment, iabp console ecg lead was not reading & iabp was not triggering.Attempted to place iabp in operator mode with ap trigger, iabp would not trigger on ap mode.Patient became symptomatic with dyspnea & chest pain; ccu fellow & attending alerted & at bedside.Perfusion paged emergently for replacement console; backup console obtained by ccu charge rn.As troubleshooting progressed, console screen began to flicker & become blurry.Iabp console was rebooted which temporarily resolved issue; iabp interruption total time approx.5mins.Perfusion staff arrived with replacement console & console was exchanged without incident or difficulty.Balloon position confirmed via cxr.Patient reports improvement of symptoms following resolution of iabp console malfunction." no report of patient harm or injury.Associated mdr 3010532612-2022-00455.

Manufacturer Narrative

(b)(4).Returned for investigation was an ac3 front end board.The sample was returned in the feb board shipping box with electrostatic protective bag.Visual inspection of the front end board was performed and no abnormality was noted.The log files were reviewed and show several alarms related to ecg and ap waveform issues around the time of the reported event.The front-end board was installed into a known good ac3 for functional testing.The pump was powered on with no abnormalities.A patient simulator was connected to the pump and pumping was initiated in autopilot.The front end board passed voltage check, bp transducer, and static ram memory.Performed ecg, ap signal and trigger checklist and passed.The pump was left to run for over 90 minutes without any alarms or errors.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of "lead and trigger failure" is confirmed based on the iabp log files.The returned front end board passed visual and functional test specifications.The alarm files showed alarms related to lead and trigger failures around the time of the alleged event.Based on a review of the device history record (dhr), the product met specification upon r elease.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

Event Description

It was reported that "at 1032, patient's iabp console began to alarm 'loss of signal'.Upon assessment, iabp console ecg lead was not reading & iabp was not triggering.Attempted to place iabp in operator mode with ap trigger, iabp would not trigger on ap mode.Patient became symptomatic with dyspnea & chest pain; ccu fellow & attending alerted & at bedside.Perfusion paged emergently for replacement console; backup console obtained by ccu charge rn.As troubleshooting progressed, console screen began to flicker & become blurry.Iabp console was rebooted which temporarily resolved issue; iabp interruption total time approx.5mins.Perfusion staff arrived with replacement console & console was exchanged without incident or difficulty.Balloon position confirmed via cxr.Patient reports improvement of symptoms following resolution of iabp console malfunction." no report of patient harm or injury.Associated mdr 3010532612-2022-00455.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15708804
• MDR Text Key: 307568592
• Report Number: 3010532612-2022-00496
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• 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: 10/19/2022

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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/12/2022
• 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