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

Model Number IPN917285

Device Problem Mechanical Problem (1384)

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

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

The called report involved a patient on a iabp yesterday and the alarms they had.They wanted to discuss what may have been going on.They had a female patient post stent placement that had a fiberoptic iab place and connected to an ac3.The fiberoptic was not zeroed prior to insertion.They calibrated the fos.Once the patient was in the unit (cvicu), the staff started getting high baseline alarms.The pump would shut off.At one time they got a high-pitched constant alarm.They wanted to discuss what may have been going on.We discussed that the high baseline alarms are helium alarms, and the pump would stop pumping and give an audible tone.We discussed that high baseline alarms are often related to a kink to the catheter and the most frequent place for the kink is at the inser tion site.She stated that they would restart the pump.I explained that the constant alarm may have occurred if they had not silent the alarm before troubleshooting the issue.She stated that they finally switched the pump out for a second ac3 pump and they did not have any more alarms.The first pump was sent to biomed.They do not have the serial number of the pump.The iab has since been removed since the patient did not need the pump any longer.I explained that the high baseline alarm may have been due to an internal issue with the pump and switching the pump out was the correct troubleshooting.I explained that it would have been helpful if the staff had called the hot line at the time for quicker troubleshooting.The caller had no other questions.

Manufacturer Narrative

(b)(4).An ac3 m-force motor driver assembly was returned for investigation by the field service agent.A visual inspection of the m-force motor driver assembly was performed.It was noted that after removal of the cables that the internal pcb was misplaced, preventing proper reinsertion of the cable.To reinsert the cable, the pcb was pushed out of the way while simultaneously pushing the connector in.After functional investigation was completed, visual inspection of the internal hardware was performed.The pcb has stand-offs on one side, so the internal wires pushed on the other side to interfere with the cable in the manner noted above.The m-force motor driver and motor driver cables were installed into a known good ac3 for functional testing.The pump was powered up successfully.Pumping was initiated.The pump was run on battery power for over 60 minutes with no alarms.The pump was then plugged into the ac power outlet and run for an additional 5 hours with no alarms.The pump was then run for 60 minutes on battery power with an increased heart rate with no alarms.The voltages and balloon volumes were checked, and all were within specifications.A device history record review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The risk is acceptable based on evaluation standards.The returned device passed visual and functional testing.The reported complaint of frequent high baseline alarms was confirmed by the field service agent; however, the returned m-force motor driver passed functional testing during complaint investigation.The root cause of this complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15513490
• MDR Text Key: 304623468
• Report Number: 3010532612-2022-00383
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 10/26/2022
• 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: A
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Sex: Female