MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC TUBING COMM:PRESS MONTR 132" W/SPECIAL E; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number 21-5841-001

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in use on a patient with an ac3 pump, the cal key did not respond and there was no iab waveform.As a result, the pump was exchanged with an ac2 pump and the cal key responded appropriately.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint for iab "cal key did not respond" was confirmed upon investigation of the returned sample.The customer returned a 35ml non-teleflex intra-aortic balloon catheter (iabc) without any original packaging for investigation.The sample was returned in a cardboard box and was in a sealed ziploc bag (inp-1, inp-2).Upon return, the teleflex fos cable, including blue fos connector and cal key, was noted assembled to the non-teleflex iabc (inp-3).No visual damage or abnormalities were noted to the returned iabc.No obvious blood was noted on the interior other exterior surfaces of the returned sample.The fos cable was visually inspected; no damage or abnormalities were noted.No visual fos fiber breaks were noted.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were intact (inp-5, inp-6, and inp-7).The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.The cal key was examined, and no damage was noted (inp-8, inp-9).The cal key code is "0174" (inp-9).The cal key and fos were connected to the iabp without difficulty.The pump displayed "fos sensor connected, connect cal key to zero" and displayed fos status "ck" (cal key), indicating that the cal key was not recognized by the iabp (anp-1, anp-2).The cal key was removed and rotated 180 degrees and then reinserted with the same result.The fos cal key was visually inspected again, and no damage was noted.The fos could not be autozeroed by the pump due to the unrecognized cal key.Upon further inspection, the fos fiber was found fully intact.A device history record (dhr) review was unable to be completed as no lot number was reported.The probable root cause of the cal key issue was supplier related.Further investigation has been initiated under teleflex's quality system to evaluate this issue.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that while in use on a patient with an ac3 pump, the cal key did not respond and there was no iab waveform.As a result, the pump was exchanged with an ac2 pump and the cal key responded appropriately.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: TUBING COMM:PRESS MONTR 132" W/SPECIAL E
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• 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: 18221422
• MDR Text Key: 329164703
• Report Number: 3010532612-2023-00670
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-5841-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1