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

Model Number IPN001112

Device Problem Mechanical Problem (1384)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was a strange bpw waveform and lack of augmentation.It was noted that the staff tried to go to operator mode, adjust triggers, change the timing, etc., but with no change.The clinical support specialist (css) had the staff switch the pump back to autopilot, which resulted in no change.The staff then cycled the power to the pump.Once the pump started back up, the staff confirmed everything looked as expected.As a precaution, the css had the staff swap to a new pump and had the reported pump sent to biomed due to the changes on the bpw.There was no report of patient complication, serious injury, or death.Update: additional information was received from field service agent on (b)(6) 2021.Biomed checked out the pump, ran it overnight, and could not find any problems.The unit was returned to service.

Event Description

It was reported that there was a strange bpw waveform and lack of augmentation.It was noted that the staff tried to go to operator mode, adjust triggers, change the timing, etc., but with no change.The clinical support specialist (css) had the staff switch the pump back to autopilot, which resulted in no change.The staff then cycled the power to the pump.Once the pump started back up, the staff confirmed everything looked as expected.As a precaution, the css had the staff swap to a new pump and had the reported pump sent to biomed due to the changes on the bpw.There was no report of patient complication, serious injury, or death.Update: additional information was received from field service agent on 11/8/2021.Biomed checked out the pump, ran it overnight, and could not find any problems.The unit was returned to service.

Manufacturer Narrative

Qn#(b)(4).The product was not returned for investigation.The reported complaint of "strange bpw waveform and lack of augmentation/afterload reduction" is confirmed based on the pictures provided in the complaint.As a result, the staff powered down the pump and back on.The hospital biomed checked the pump and no problem was found with the pump.No part was returned to teleflex chelmsford for investigation.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.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 INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 12860823
• MDR Text Key: 281157896
• Report Number: 3010532612-2021-00355
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Male