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

Model Number IPN001112

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the field service engineer (fse) that the intra-aortic balloon pump (iabp) did not activate the audio alarm when the condition occurred.The user had a "running on battery" reporting the alarm volume interface was grayed out.It was reported that the patient outcome was good as the pump worked correctly despite the alarm problem.The pump has been checked without any evidence, with a two hours test.The iabp did not reveal any problem related to any audio alarms.There was no report of patient injury or consequence.

Manufacturer Narrative

Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "iabp did not activate the audio alarm when the condition occurred" is not confirmed.A field service engineer checked the pump and could not replicate the issue.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported by the field service engineer (fse) that the intra-aortic balloon pump (iabp) did not activate the audio alarm when the condition occurred.The user had a "running on battery" reporting the alarm volume interface was grayed out.It was reported that the patient outcome was good as the pump worked correctly despite the alarm problem.The pump has been checked without any evidence, with a two hours test.The iabp did not reveal any problem related to any audio alarms.There was no report of patient injury or consequence.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• MDR Report Key: 9677365
• MDR Text Key: 184670590
• Report Number: 3010532612-2020-00038
• 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: 01/20/2020

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: 01/20/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1