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

Model Number	IPN917288
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient the iabp printer had difficulty printing and the paper that did print out had burnt edges.A small amount of smoke was observed as well.The issue was resolved by replacing the printer with a demo printer.No report of harm or injury to the patient, the patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of "printer burn" is confirmed based on the photos received from the customer.No part was returned to teleflex chelmsford for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the burnt recorder paper.The root cause of the complaint is undetermined.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.A non-conformance has been initiated to further investigate the issue.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient the iabp printer had difficulty printing and the paper that did print out had burnt edges.A small amount of smoke was observed as well.The issue was resolved by replacing the printer with a demo printer.No report of harm or injury to the patient, the patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "printer burn" was confirmed based on the investigation of the returned sample.The customer returned for investigation an ac3 recorder assembly (part number: 33-3021-001, s/n: (b)(6) ).The sample was returned in a brown cardboard box with protective shipping packaging (inp-1 through inp-2).Visual inspection of the recorder assembly was performed (inp-3 through inp-12).Brown stains consistent with overheating were noted on the plastic housing (inp-10) and residue/corrosion was noted on the pcb (inp-12).No other abnormality was noted.A functional testing with the iabp was not performed due to the returned state of the device.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the damaged recorder pcb components.The most probable root cause was saline coming into contact with the top of the recording assembly pcb.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient the iabp printer had difficulty printing and the paper that did print out had burnt edges.A small amount of smoke was observed as well.The issue was resolved by replacing the printer with a demo printer.No report of harm or injury to the patient, the patient status is reported as "fine".

• Brand Name: AC3 IABP NA/AJLA
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15691457
• Report Number: 3010532612-2022-00483
• Device Sequence Number: 17847980
• Product Code: DSP
• UDI-Device Identifier: 10801902172096
• UDI-Public: 10801902172096
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup
• Report Date (Section B): 10/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN917288
• Device Catalogue Number: IAP-0601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 12/26/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 12/12/2022; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown