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 01/30/2023

Event Type  malfunction  

Event Description

Reported as "loss of ap trigger with ap waveform and pressures present on pump".It was reported that an "initial call to the hotline for assistance with difficulty pumping in ap trigger, when switching to ap trigger, hr 'dramatically increases and pumping is erratic'.Troubleshooting/assessment done via facetime.Large amounts of artifact noted on ap waveform causing erratic triggering.Perfusionist is getting ready for when bovi is used.Pump is pumping appropriately in ecg trigger.No movement or interference noted on transducer or ap tubing, cable switched, radial a-line connected briefly to pump and no artifact noted on radial ap waveform.Transducer set up exchanged, no noted ap artifact.However, when ecg signal disconnected to force pump to ap trigger, trigger loss alarm occurred, pumping stopped.Pump switched back to ecg when plugged back in and pumping resumed.This was repeated multiple times with no change.Operator and autopilot modes attempted.Ap waveform present on screen, accurate pressures noted, pump not identifying waveform.Second pump brought in and ap cable connected and trigger verified on second pump.Pump exchanged and sent to biomed." no patient injury or consequence.No delay in therapy.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4), returned for investigation was an ac3 front end board (feb) (p/n: 33-1020-003, s/n: (b)(6)).The sample was returned in an feb board shipping box with an electrostatic protective bag.Visual inspection of the front end board was performed and no abnormality was noted.The customer provided photos were reviewed.The photos showed irregular ap waveforms, which is consistent with the reported complaint.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 with an ap trigger in operator mode.The front end board passed voltage check, bp transducer, and static ram memory.Performed ecg, ap signal and trigger checklist and passed.The trigger was switched from ecg to ap while pumping; the heart rate remained consistent, no abnormalities were noted.The pump was left to run for approximately 1 hour on battery power and no alarms or errors were noted.A device history record (dhr) review was conducted for the serial number/lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The risk is acceptable.The returned device passed visual and functional testing.The reported complaint of "when switching to ap trigger, hr dramatically increases and pumping is erratic" is not confirmed.The returned front-end board passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.This will be monitored for any developing trends.

Event Description

Reported as "loss of ap trigger with ap waveform and pressures present on pump".It was reported that an "initial call to the hotline for assistance with difficulty pumping in ap trigger, when switching to ap trigger, hr 'dramatically increases and pumping is erratic'.Troubleshooting/assessment done via facetime.Large amounts of artifact noted on ap waveform causing erratic triggering.Perfusionist is getting ready for when bovi is used.Pump is pumping appropriately in ecg trigger.No movement or interference noted on transducer or ap tubing, cable switched, radial a-line connected briefly to pump and no artifact noted on radial ap waveform.Transducer set up exchanged, no noted ap artifact.However, when ecg signal disconnected to force pump to ap trigger, trigger loss alarm occurred, pumping stopped.Pump switched back to ecg when plugged back in and pumping resumed.This was repeated multiple times with no change.Operator and autopilot modes attempted.Ap waveform present on screen, accurate pressures noted, pump not identifying waveform.Second pump brought in and ap cable connected and trigger verified on second pump.Pump exchanged and sent to biomed." no patient injury or consequence.No delay in therapy.

• 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: 16306335
• MDR Text Key: 309052706
• Report Number: 3010532612-2023-00076
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

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
• 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: 01/30/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 03/22/2023
• 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
• Patient Sex: Female