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

Model Number	IPN917286
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3013162291-2022-00005
• Device Sequence Number: 17604659
• Product Code: DSP
• UDI-Device Identifier: 10801902172072
• UDI-Public: 10801902172072
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown