MAUDE Adverse Event Report: 3M HEALTH CARE 3M HIGH FLOW RANGER FLUID WARMING SET; HIGH FLOW DISPOSABLE TUBING

Model Number 24355

Device Problem Material Rupture (1546)

Patient Problem Death (1802)

Event Date 06/19/2014

Event Type  Death  

Event Description

A nurse from the hosp emergency room reported that (b)(6) yr old man was seen in the emergency room on (b)(6) 2014 following a traumatic car accident.The man was noted to have life-threatening injuries from the car accident.While in the emergency room, the man received one liter of normal saline and 2 units of packed red blood cells via a model #14500 ranger pressure infusor (serial no.(b)(4)), warming unit, and model #24355 high flow disposable tubing without problem.The tubing was changed between the infusions.Both sets of tubing were from lot hx7355.The man was transferred to the intensive care unit around midnight where he received one unit of packed red blood cells using the ranger pressure infusor, warming unit, and model #24355 high flow disposable tubing.The tubing was new and was of the same lot hx7355 as the previous 2 sets of tubing.During the infusion, the nurse noticed that the fluid flow had stopped.The nursed assessed the iv site and checked that all clamps were open.There was an alleged rupture of the tubing with blood spraying on three nurses around the room.A new unit of packed red blood cells was attached to new tubing of a different lot.The infusion was restarted without problem.The pt had a traumatic code which was stopped.The pt expired on (b)(6) 2014.The treating physician believed that the man's death was related to the car accident and not the result of the device malfunctioning.

Manufacturer Narrative

Visual eval of returned set showed excessive physical damage at outlet port.Adhesive bond of tube to frame was broken and vinyl along feedthrough tube was torn.Both areas are outside fluid path and would not have been caused by fluid pressure.Damage could only have been caused external forces applied to product during set up and handling.Closer eval showed fluid path torn at seam near outlet port which could have been damaged at same time as external device elements or caused by internal fluid pressure.Damage from internal pressure is unlikely.Pressure infusor model 145 which was connected to fluid warming set during event and maintains controlled pressure was tested by facility and found to be operating within specification.No failures of this magnitude have been observed by manufacturer even under challenge conditions.Method: testing the device for problems that result from external forces including fluids, other objects, or environmental or physiologic influences.Results: device problems that result from internal or external forces including fluids, other objects or environmental or physiologic influences.Conclusions: a device related to the operator's technique or use environment.

• Brand Name: 3M HIGH FLOW RANGER FLUID WARMING SET
• Type of Device: HIGH FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer Contact: linda johnsen, ra ; 2510 conway ave; st.paul, MN 55144 ; 6517374376
• MDR Report Key: 3999472
• MDR Text Key: 4688686
• Report Number: 2110898-2014-00052
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: 24355
• Device Lot Number: HX7355
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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 Outcome(s): Death
• Patient Age: 84 YR