MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC IV MTG. KIT W/SAFESET

Model Number 42646-06

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Pending receipt of involved device(s).

Event Description

Complaint received reporting reading/transducer issues with use of 42646-06 transpac iv mtg.Kit.The initial information received reports ".(b)(6) 2016 after an arterial line was placed.Once connected, it would not transduce.A second set was primed and connected, which lasted less than 12 hours, and failed to transduce.It was replaced by a 3rd set in the a.M.Of (b)(6) (same patient).In the afternoon this set failed also.Replaced it with a pa-catheter set.".There were no reported adverse pt.Consequences.Additional event information and return of the involved devices although requested has not been responded to,.

• Brand Name: TRANSPAC IV MTG. KIT W/SAFESET
• Type of Device: TRANSPAC IV MTG. KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 6028631
• MDR Text Key: 57426290
• Report Number: 2025816-2016-00163
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: 42646-06
• Device Catalogue Number: 42646-06
• Device Lot Number: 3261710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1