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

Model Number IPN001112

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

There was no patient involvement.It was reported that a purge failure occurred during preventative maintenance (pm) on the intra-aortic balloon pump (iabp).As a result, the pcs was replaced.

Manufacturer Narrative

Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of purge failure alarm is confirmed.The returned pcs assembly's balloon pressure transducer zero offset was noted to be above specification during the complaint investigation, which caused the alarm.The root cause of this 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.A non-conformance has been initiated to further investigate the issue.

Event Description

There was no patient involvement.It was reported that a purge failure occurred during preventative maintenance (pm) on the intra-aortic balloon pump (iabp).As a result, the pcs was replaced.

• 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: 11309286
• MDR Text Key: 231318378
• Report Number: 3010532612-2021-00027
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1