MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, LLC HEMOTHERM; CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER,

Model Number 400CE

Device Problems Loss of Power (1475); Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

Csz received complaint (b)(4) indicating the device stopped pumping and the keyboard was unresponsive.Evaluation identified the device had low flow due to clogged water filter.[(b)(4)].

Event Description

The customer states the device stopped pumping water during a case.The unit was operating at 32c and lost power.When the unit was powered back up the keyboard was unresponsive at first.The unit was switched out and the case was finished.There was no patient harm.

Manufacturer Narrative

Service evaluation confirmed the customer issue.Device would not pump due to a clogged water filter.The filter was replaced to correct.

• Brand Name: HEMOTHERM
• Type of Device: CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER,
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, LLC; 12011 mosteller road; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller road; cincinnati, OH 45241 ; 5133265295
• MDR Report Key: 7898799
• MDR Text Key: 121715859
• Report Number: 1516825-2018-00015
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 400CE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1