MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. THERMODILUTION CATH KIT: 7.5 FR 5-L; HANDS-OFF THERMODILUTION CATHETER

Catalog Number AH-05050-PU

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2015

Event Type  malfunction  

Event Description

It has reported that the event occurred in the theatre during insertion.The anesthetist connected the ah-05050-pu to the cardiac output syringe set.The cables were checked and inserted via internal jugular.The lines were easily flushed.No temperature with cardiac output program was noted.As a result, the device was removed.A new catheter was inserted and the procedure went on as planned successfully.There was no report of pt death, complications, injury, or medical / surgical intervention required.There was a delay or interruption in therapy with no harm to the pt noted.

Manufacturer Narrative

Qn # (b)(4).

• Brand Name: THERMODILUTION CATH KIT: 7.5 FR 5-L
• Type of Device: HANDS-OFF THERMODILUTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 235/47; zdar nad sazavou 591 01; EZ 591 01
• Manufacturer Contact: kathryn myers, reg associate ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4580007
• MDR Text Key: 5337820
• Report Number: 3006425876-2015-00061
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K833918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: AH-05050-PU
• Device Lot Number: 71F13L0773
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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