MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/AJLA; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN917286

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that: "cma educator and tm were running an iabp education session in icu on (b)(6) 2022 at (b)(6).During the session we noted that the condensate bottle at the back of the pump had a discoloured liquid in it.Notified staff from (b)(6)- asked to get a urine dipstick to check if it is blood.Upon dipstick test noted to be positive for blood.Staff unsure when the pump was last on a patient and nature of the incident".Additional information has been requested to the customer.No additional details have been provided.

Event Description

It was reported that:"cma educator and tm were running an iabp education session in icu on 13/5/22 at rmh.During the session we noted that the condensate bottle at the back of the pump had a discoloured liquid in it.Notified staff from rmh - asked to get a urine dipstick to check if it is blood.Upon dipstick test noted to be positive for blood.Staff unsure when the pump was last on a patient and nature of the incident".Additional information has been requested to the customer.No additional details have been provided.

Manufacturer Narrative

(b)(4).The reported complaint of blood in the condensation bottle is not able to be confirmed.No iab rupture was reported to teleflex from the customer.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

• Brand Name: AC3 OPTIMUS IABP NA/AJLA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section G): ARROW INTERNATIONAL LLC; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15161095
• MDR Text Key: 302475126
• Report Number: 3013162291-2022-00005
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902172072
• UDI-Public: 10801902172072
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN917286
• Device Catalogue Number: IAP-0701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED