MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ BAIR HUGGER¿ FULL ACCESS UNDERBODY WARMING BLANKET; DISPOSABLE THERMAL BLANKET

Model Number N/A

Device Problems Device Issue (2379); Improper Device Output (2953); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hypothermia (1915)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

This product does not include an expiration date for it is sold as a non-sterile product.No formal number has been provided from fda as to our recall.The following caution statement is included in the instructions for use regarding 63500 blanket.3m was not able to confirm if patient was monitored as suggested in our labeling." caution: to reduce the risk of thermal injury, hyperthermia or hypothermia: 3m recommends continuously monitoring core temperature.In the absence of continuous monitoring, monitor the temperature of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol.".

Event Description

Patient went into hypothermia after use of a warming blanket.The patient's hypothermia temperature was at 35.2°c.This patient was previously operated for an endoluminal mitral valve.Then, in post-operative phase, the patient had to be maintained under anesthesia and sent to the intensive care unit until recovery of a normal body temperature.It was observed the left lateral bolster seal to the distal end of the blanket did not allow for air circulation in the area of the patient's legs and along side the patient's body which resulted in a lack of warming.

• Brand Name: 3M¿ BAIR HUGGER¿ FULL ACCESS UNDERBODY WARMING BLANKET
• Type of Device: DISPOSABLE THERMAL BLANKET
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; eden prairie MN 55344
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 7229320
• MDR Text Key: 98630068
• Report Number: 2110898-2018-00014
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 50707387775129
• UDI-Public: 50707387775129
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 63500
• Device Lot Number: R10362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2017
• 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): Other