MAUDE Adverse Event Report: SMITHS MEDICAL SMITHS MEDICAL FLUID WARMER; HOTLINE

Model Number CON-HL-390

Device Problems Device Sensing Problem (2917); Temperature Problem (3022)

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

Event Date 12/21/2016

Event Type  malfunction  

Event Description

We've had at least fourteen reports of problems with the smith's medical hotline blood warmers since june of 2016.Ten different devices have been reported.We have 32 devices in active inventory.The post frequent problem (9 reports) has involved a mechanical sensing switch that prevents warmer operation when it fails to detect an installed tubing set.Four times we have placed the circulating fluid due to visible discoloration or contamination.(one report was a request to inspect the unit after an external fluid spill, but no repair or adjustment was needed.) our sister hospital reports that they are seeing discoloration almost sludge looking fluids and have discontinued use of the hotlines.Our techs have observed occasional slo leaks around the tubing.The anesthesia techs are reporting the tubing is leaking even after waiting the required time for the fluid to quit re-circulating after turning off the machine.The issue has been reported to the mfr waiting on a reply from the mfr to find out they're aware of problems such as we've experienced and if they have any suggestions for preventing them.

• Brand Name: SMITHS MEDICAL FLUID WARMER
• Type of Device: HOTLINE
• Manufacturer (Section D): SMITHS MEDICAL; morgantown WV 26505
• MDR Report Key: 6202074
• MDR Text Key: 63278764
• Report Number: MW5066875
• Device Sequence Number: 1
• Product Code: BSB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CON-HL-390
• Device Catalogue Number: L-370 WARMING SET
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1