MAUDE Adverse Event Report: ST PAUL LEVEL 1 EQUATOR CONVECTIVE WARMING DEVICE; SYSTEM, THERMAL REGULATING

Model Number SWU-2013

Device Problem Inadequate User Interface (2958)

Patient Problems Hemorrhage/Bleeding (1888); Low White Blood Cell Count (4433)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported that the patient was bleeding from neck, anesthetic had covered with a pressure dressing.Patient's hgb dropped from approximately 147 to approximately 76.At the end of the case, as drapes were removed, it was noted that the bottom chamber of the underbody snuggle warmer on the patients right side was full of blood, was just reaching the level where it was starting to spurt out of the air holes.It was then noted that the neck had been bleeding throughout the procedure-pressure dressing sopping wet, blood dripped down bleeding the neck and into the warming blanket.Intervention required transfusions of blood to the patient to combat the dropped hgb in the or, but was fine post op.Reporter indicated they had did not expect this as a possibility and wanted to make the reporting manufacturer aware, although they do not allege the device worked improperly.

Manufacturer Narrative

Other text: no lot or serial number was provided; therefore, device history record review could not be performed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.E4 is unknown in h10.

• Brand Name: LEVEL 1 EQUATOR CONVECTIVE WARMING DEVICE
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15201856
• MDR Text Key: 297632650
• Report Number: 3012307300-2022-15174
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10610586043413
• UDI-Public: 10610586043413
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SWU-2013
• Device Catalogue Number: SWU-2013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male