MAUDE Adverse Event Report: 3M HEALTH CARE 3M ¿ BAIR HUGGER¿ WARMING UNIT; HYPER/HYPOTHERMA SYSTEM

Model Number 505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Burn, Thermal (2530); Superficial (First Degree) Burn (2685)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

Expiration date is not applicable to the unit nor udi.This product has been discontinued in the market.This report was indicated as "serious injury" due to age/size of infant, and not based on seriousness of the burn itself.The burn was resolved with minimal intervention.The unit was evaluated and found to not meet its performance specifications.This unit operates under 120v so model reflects 505 but catalog number is 50500.Model 505 has been marketed globally but was discontinued a few years ago.The unit requires use of a disposable.The unit should not cause a burn if used according to its instructions and that includes the use of disposables.The disposables are indicated for single use.The disposable is being returned by the customer for evaluation and investigation is pending.An investigation and analysis was conducted of the referenced bair hugger ¿ unit.It was determined that the unit appeared to be abused and damaged.The unit arrived without a hose assembly.The filter was also clogged with debris and had large hole in the elbow assembly.The unit failed the ot test at 50.5 degrees c where the minimum spec os 52.0 degrees c.The unit failed all remaining temperature tests as well.The measurements were on the low side of specification.The low values could have been caused by the large hole in the elbow assembly which appeared to be caused by damage.The reported burn injury may have been a result of improper routine or preventative maintenance.End of report.

Event Description

A hospital employee reported that a 3m ¿ bair hugger ¿ novaplus ¿ pediatric underbody (model 45534) and a 3m ¿ bair hugger ¿ warming unit (model 50500) was used during a procedure in the cath lab on a (b)(6) old, white male infant, weighing (b)(6).The employee reported the patient was undergoing pericardiocentesis with drain placement.The patient was not on bypass.Pre-op, the patient's temperature was monitored using a temporal thermometer.Chloraprep was applied to the patients' chest for skin antisepsis.A patient procedure drape was placed over the warming blanket.During the surgery, the patient was warmed for 74 minutes, on high setting, in a supine position, using the foot hose port.A safety strap was not used.During this time, the patient's temperature was monitored via nasal probe.The warming temperature was not adjusted during the surgery.The procedure drapes were removed at the end of the surgery.At this time, the employee alleged it appeared the patient was burned from the shoulder to the leg on the left side of body.The employee alleged the patient's skin was red.No blistering on the skin was noted.A photo of the burn was provided which reflected skin redness and red blotches on the left side of patient's body from the shoulder to the leg.Cold compresses were applied along the length of the reddened skin at the anesthesiologist's direction.The operating physician was also notified.The employee reported the cold compresses significantly reduced the redness, but did not eliminate it.The warming unit and blanket were immediately pulled from service.The employee reported they were not made aware of any further complications the patient had related to this incident.The patient was discharged from the hospital on (b)(6) 2018.

• Brand Name: 3M ¿ BAIR HUGGER¿ WARMING UNIT
• Type of Device: HYPER/HYPOTHERMA SYSTEM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave.; 3m center, building 275-5w-06; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; eden prairie MN 55344
• Manufacturer Contact: dianne gibbs ; 2510 conway ave; 3m center, building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 7688234
• MDR Text Key: 114001286
• Report Number: 2110898-2018-00076
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2018

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: 505
• Device Catalogue Number: 50500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 MO
• Patient Weight: 5