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

Catalog Number IAP-0700

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) when in use, the staff noted that the display was "distorted, nonresponsive to touch, and intermittent".As a result, the pump was switched out quickly.There was no report of patient complication or serious injury and death.

Event Description

It was reported that the intra-aortic balloon pump (iabp) when in use, the staff noted that the display was "distorted, nonresponsive to touch, and intermittent".As a result, the pump was switched out quickly.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "touchscreen unresponsive" is not able to be confirmed.The field service engineer could not duplicate the issue.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 risks.The complaint will be monitored for any developing trends.No further action required at this time.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "touchscreen unresponsive" is not able to be confirmed.The field service engineer could duplicate the issue.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 risks.The complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon pump (iabp) when in use, the staff noted that the display was "distorted, nonresponsive to touch, and intermittent".As a result, the pump was switched out quickly.There was no report of patient complication or serious injury and 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: 7978584
• MDR Text Key: 124130105
• Report Number: 3010532612-2018-00319
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902084965
• UDI-Public: 00801902084965
• 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: 09/24/2018

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 Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 11/16/2018; 11/16/2018
• Supplement Dates FDA Received: 11/19/2018; 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1