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

Combination Product (Y/N)

• 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

0 PatientS WERE 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
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage