MAUDE Adverse Event Report: 3M RANGER PRESSURE INFUSER MODEL 145; TUBING

Model Number 145

Device Problems Material Rupture (1546); Device Contamination with Body Fluid (2317)

Patient Problem Death (1802)

Event Date 06/19/2014

Event Type  malfunction  

Event Description

During a cardiac arrest of a trauma patient, patient was receiving prbc via a 3m ranger pressure infuser model 145, 3m ranger blood warming system model #245, using 3m tubing.During the infusion the blood tubing ruptured causing blood to spew all over the patient's room and 3 staff members assisting with the resuscitation.The post event review revealed no operator error.Patient had received 2 units prbc's & 1 unit normal ns in the ed prior to transfer to icu from a different ranger pressure infusion system without incident.Tubing for both of these events was from the same lot# (hx7355) and expiration date (b)(6) 2016.Following this malfunction, tubing from a different lot number was successfully used with the same ranger unit to infuse an additional unit of prbc's.

• Brand Name: 3M RANGER PRESSURE INFUSER MODEL 145
• Type of Device: TUBING
• MDR Report Key: 3932716
• MDR Text Key: 49248064
• Report Number: MW5037225
• Device Sequence Number: 1
• Product Code: BSB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: 145
• Device Catalogue Number: 145
• Device Lot Number: HX7355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR