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

Model Number IPN001112

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was a slow (dripping) leaking saline bag, the intra-aortic balloon pump (iabp) screen went black and a constant 5-volt alarm occurred while on the patient.As a result, the iabp was switched.There was no report of patient complications, serious injury or death.

Event Description

It was reported that there was a slow (dripping) leaking saline bag, the intra-aortic balloon pump (iabp) screen went black and a constant 5-volt alarm occurred while on the patient.As a result, the iabp was switched.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "the screen went black and constant 5-volt alarm" is confirmed.Upon return, the unknown residues were found at several locations on the pcb as well as the damaged components c608 and j402.Rust was noted on the connector of dvi cable.These findings were found during visual inspection which was the cause of the reported issue.The root cause of this complaint is undetermined.A potential cause of component damaged due to contact of saline fluid.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 revived risk.This will be monitored for any developing trends.

• 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: 11413194
• MDR Text Key: 240370184
• Report Number: 3010532612-2021-00049
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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: 02/15/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1