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

Model Number IPN001112

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the intra-aortic balloon pump (iabp) touchscreen froze up during use.The staff exchanged for another iabp after trying screen calibration, cursor movement and power recycling the iabp.The patient had remained stable and supported on the iabp with no other noted alarms or issues.Patient was successfully supported on the second iabp without issue.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).No iabp part or recorder strip has been returned to teleflex chelmsford for investigation.The reported complaint of iabp touch screen unresponsive is not able to be confirmed.Per the event details, the pump was powered on after being powered off for more than 5 minutes, and the issue did not reoccur.The root cause of the complaint is undetermined.Device history record (dhr) review was conducted for the lot 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 revived risk.This will be monitored for any developing trends.

Event Description

It was reported the intra-aortic balloon pump (iabp) touchscreen froze up during use.The staff exchanged for another iabp after trying screen calibration, cursor movement and power recycling the iabp.The patient had remained stable and supported on the iabp with no other noted alarms or issues.Patient was successfully supported on the second iabp without issue.There was no report of patient complications, serious injury or death.

• 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: 9649379
• MDR Text Key: 184648048
• Report Number: 3010532612-2020-00010
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• 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
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1