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

Model Number IPN001112

Device Problem Failure to Run on Battery (1466)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) was in the or all day, plugged in and was working fine.The iabp turned completely off when the staff unplugged it.The staff was able to plug the iabp back in and was able to restart.When the staff unplugged it again, the same thing occurred.As a result, the iabp was swapped out.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "ecg signal loss" is not confirmed.The returned front-end board passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the intra-aortic balloon pump (iabp) was in the or all day, plugged in and was working fine.The iabp turned completely off when the staff unplugged it.The staff was able to plug the iabp back in and was able to restart.When the staff unplugged it again, the same thing occurred.As a result, the iabp was swapped out.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon pump (iabp) was in the or all day, plugged in and was working fine.The iabp turned completely off when the staff unplugged it.The staff was able to plug the iabp back in and was able to restart.When the staff unplugged it again, the same thing occurred.As a result, the iabp was swapped out.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "ecg signal loss" is not confirmed.The returned front-end board passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Corrected data: an error was made when submitting the follow-up.No analysis of production records was made, as the returned sample has no confirmed product failure.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11201909
• MDR Text Key: 227781258
• Report Number: 3010532612-2021-00019
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (y/n): N
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1