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

Catalog Number IAP-0700

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For complaint involving the same event see mdr #3010532612-2019-00267 and tc (b)(4).

Event Description

It was reported that when the intra-aortic balloon pump (iabp) was in use, the staff noted the pump had stopped pumping and no alarms were heard.As a result, the staff cycled power the pump and the pump functioned normally.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).For complaint involving the same event see mdr #3010532612-2019-00267 and tc #1900070919.Teleflex received the device for investigation.The reported complaint of iabp stopped pumping without alarm is not able to be confirmed.The pump was serviced by a teleflex field service engineer and the issue could not be duplicated.The returned front end board passed functional testing.The root cause of the complaint is undetermined.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.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that when the intra-aortic balloon pump (iabp) was in use, the staff noted the pump had stopped pumping and no alarms were heard.As a result, the staff cycled power the pump and the pump functioned normally.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: 8895319
• MDR Text Key: 156599296
• Report Number: 3010532612-2019-00268
• Device Sequence Number: 1
• Product Code: DSP
• 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
• Report Date: 07/26/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1