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U.S. Department of Health and Human Services

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

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3M HEALTH CARE 3M ¿ BAIR HUGGER¿ WARMING UNIT HYPER/HYPOTHERMA SYSTEM Back to Search Results
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.

 
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Brand Name3M ¿ BAIR HUGGER¿ WARMING UNIT
Type of DeviceHYPER/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 Key7688234
MDR Text Key114001286
Report Number2110898-2018-00076
Device Sequence Number1
Product Code DWJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK960167
Number of Events Reported1
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
Date FDA Received07/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number505
Device Catalogue Number50500
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/13/2018 Patient Sequence Number: 1
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