MAUDE Adverse Event Report:; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Failure to Deliver (2338)

Patient Problems Burn(s) (1757); Surgical procedure, additional (2564)

Event Date 04/23/2015

Event Type  Injury  

Event Description

Per medsun report received from the fda on 13july2015: this was a continuous renal replacement therapy.Cacl running on right groin line extravasation.This is the second infiltration that occurred on this (b)(6) male patient.This caused all medications running through this line to be stopped.Lost pulses on the right dp (distal pulse) and they had to stop the crrt treatment.It caused a third degree burn requiring plastic surgery debridement and grafting.All medication were then initiated to the ecmo circuit including the crrt treatments and cacl administration.The patient required plastic surgery debridement and grafting due to this event.

Manufacturer Narrative

Brand name, device, (b)(4).The event is currently under investigation.Corrected data: brand name, device, manufacturer, exp.Date 02/01/2016, (b)(4), device not returned.Brand name, device, (b)(4).The event is currently under investigation.Corrected data: brand name, device, manufacturer, exp.Date 02/01/2016, (b)(4).Device not returned.

• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4976301
• MDR Text Key: 17302110
• Report Number: 1820334-2015-00476
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015,07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-501J-ABRM-HC-FST
• Other Device ID Number: SEE FIELD H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2015
• Distributor Facility Aware Date: 04/23/2015
• Device Age: 21 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2013
• 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
• Patient Age: 1 YR
• Patient Weight: 11