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

Model Number IPN001112

Device Problems Pumping Stopped (1503); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a clinical support specialist (css) that the pump had a system error 7 sub code 16 and stopped pumping during an in service.The iab volume was reading 0 and 0%.When the 100% full volume was touched it still remained at 0.The css touched the full volume and apply, and the pump completed a purge cycle and the screen displayed the correct volume.There was no patient involvement.

Event Description

It was reported by a clinical support specialist (css) that the pump had a system error 7 sub code 16 and stopped pumping during an in service.The iab volume was reading 0 and 0%.When the 100% full volume was touched it still remained at 0.The css touched the full volume and apply, and the pump completed a purge cycle and the screen displayed the correct volume.There was no patient involvement.

Manufacturer Narrative

Qn#(b)(4).Teleflex did not receive the device for investigation.The reported complaint of system error 7 and screen restarts is confirmed by a teleflex field service engineer and the photos submitted with the complaint.A teleflex field service engineer was able to duplicate the screen reset issue when the display brightness keys are rapidly pressed.The root cause of this complaint is software related.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.A non-conformance has been initiated to further investigate the issue.

Manufacturer Narrative

Qn#(b)(4).Please note: a correction is being made to the result code and conclusion code and therefore the follow-up is being resubmitted.Teleflex did not receive the device for investigation.The reported complaint of system error 7 and screen restarts is confirmed by a teleflex field service engineer and the photos submitted with the complaint.A teleflex field service engineer was able to duplicate the screen reset issue when the display brightness keys are rapidly pressed.The root cause of this complaint is software related.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.A non-conformance has been initiated to further investigate the issue.

Event Description

It was reported by a clinical support specialist (css) that the pump had a system error 7 sub code 16 and stopped pumping during an in service.The iab volume was reading 0 and 0%.When the 100% full volume was touched it still remained at 0.The css touched the full volume and apply, and the pump completed a purge cycle and the screen displayed the correct volume.There was no patient involvement.

• 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: 9671470
• MDR Text Key: 184670482
• Report Number: 3010532612-2020-00033
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

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: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 03/06/2020; 03/06/2020
• Supplement Dates FDA Received: 03/13/2020; 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1