MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. DUAL COOLER/HEATER; SARNS DUAL COOLER/HEATER

Model Number 11160

Device Problems Device Reprocessing Problem (1091); Device Maintenance Issue (1379)

Patient Problem Not Applicable (3189)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

The field svc rep (fsr) reported that during preventative maintenance (pm) of the device, the cooler heater unit would not rewarm.This is a standby unit that very rarely gets used.Since the event occurred during preventative maintenance, there was no pt involvement.

Manufacturer Narrative

The reported complaint was confirmed by the field svc rep (fsr).The fsr found that water was flowing through the tank during warming.He found a lot of build-up from lack of use/cleaning.The fsr cleaned a normally "closed" valve and it resolved the reported issued.The unit operated to manufacturer specifications and was returned to clinical use.No parts will be returned.If add'l info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: DUAL COOLER/HEATER
• Type of Device: SARNS DUAL COOLER/HEATER
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3869872
• MDR Text Key: 4456667
• Report Number: 1828100-2014-00291
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11160
• Device Catalogue Number: 11160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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