MAUDE Adverse Event Report: CINCINNATI SUB ZERO HEMOTHERM; HEATER/COOLER

Model Number 12/15/2015 - HPC CULTURE=26,000 CFU/ML

Device Problem High Test Results (2457)

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

Event Date 12/23/2015

Event Type  malfunction  

Event Description

Per (b)(6) recently released guidance and recommendations for hospitals of (b)(6), we are reporting that 5 of our csz hemotherm hcu have tested above the epa standard (500 cfu/ml) as demonstrated by results of hpc cultures listed below.

• Brand Name: HEMOTHERM
• Type of Device: HEATER/COOLER
• Manufacturer (Section D): CINCINNATI SUB ZERO; cincinnati OH 45241
• MDR Report Key: 5332819
• MDR Text Key: 34737166
• Report Number: MW5058782
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2015
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12/15/2015 - HPC CULTURE=26,000 CFU/ML
• 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