MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SNUGGLE WARM PEDIATRIC CONVECTIVE WARMING BLANKET; SYSTEM, THERMAL REGULATING

Model Number	SWU-2009
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Rash (2033); Burn, Thermal (2530); No Code Available (3191)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Foreign : (b)(6).(b)(4).Thermal burn was another patient code used as there was no information to confirm what level of degree burn the patient received (e.G.Second degree burn).
Event or Problem Description
Information was received that a smiths medical snuggle warm pediatric convective warming blanket was used for approximately five and a half hours on an infant during cardiac surgery.Initially, the product was disinfected with chlorhexidine and was set to 40 degrees celsius for the first one and a half hours of use.The patient was positioned above the blanket during the operation, and their buttocks were laid on the portion of the blanket where a shoulder should be applied to.The next two hours, the product was used with the blowing setting (room air reported to be about 22 degrees).Extracorporeal circulation was conducted using an artificial cardiopulmonary apparatus and air was kept ventilated.The patient was monitored by rectal, skin, and pharyngeal temperature measurements.It was noted at an unspecified time that the rectal temperature felt "higher than usual".For the remaining two hours of use, while the patient recovered from anesthesia, the blanket was warmed up to 36 degrees celsius.It was then discovered after the operation that the patient sustained five to six red rashes (sized eight to ten mm) at the sides of the infant's buttocks.The following day, it was reported the rashes developed into blisters.It was also reported the "patient was treated for burn," but detail regarding the medical treatment and outcome is unknown.No additional adverse patient effects were reported.

• Brand Name: SNUGGLE WARM PEDIATRIC CONVECTIVE WARMING BLANKET
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8097655
• Report Number: 3012307300-2018-08380
• Device Sequence Number: 19519229
• Product Code: DWJ
• UDI-Device Identifier: 10610586043383
• UDI-Public: 10610586043383
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Model Number: SWU-2009
• Device Catalogue Number: SWU-2009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR