MAUDE Adverse Event Report: BAXTER / STIHLER ELECTRONIC GMBH BAXTER WARMING SHEATH; WARMER, THERMAL, INFUSION FLUID

Model Number PF2-WP33

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  Injury  

Event Description

The customer reported warning sheath (product code: unk, serial number: (b)(4)) and the ref number is pf2-wp33.The prismaflex machine was set-up and primed for an els treatment when smoke was noticed coming from the warning sheath.The sheath was immediately unplugged, removed, and sent to biomed for inspection.The renal nurse practitioner examined the blood lines and they did not appear to be affected, so treatment was started with a new sheath.Picu bedside rn and parent observed smoking from the crrt warmer line.Cause: blood warmer "sheath" that houses the return crrt blood line began smoking and burned a small hole in the "sheath" / covering - "sheath" / covering assessed and noted burn; apparently event occurred at other organizations as well.Great catch and no harm to pt but could have detrimental outcome it burned into venous return line.Fda safety report id# (b)(4).

• Brand Name: BAXTER WARMING SHEATH
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BAXTER / STIHLER ELECTRONIC GMBH
• MDR Report Key: 9075832
• MDR Text Key: 159042094
• Report Number: MW5089817
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PF2-WP33
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 17 YR