MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-80

Device Problems Fluid/Blood Leak (1250); Moisture Damage (1405); Material Puncture/Hole (1504); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that there was a puncture in the patient side tank coil which caused water damage to the compressor.There was no patient injury.

Manufacturer Narrative

The initially reported description of the event was incorrect and was part of the troubleshooting performed by the service representative.The correct failure description is: sorin group (b)(4) received a report that the sorin heater-cooler system 3t displayed multiple error messages during a procedure.There was no report of patient injury.Sorin group (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Soring group received a report that there was a puncture in the patient side tank coil which caused water damage to the compressor.There was no patient injury.The initial event description detailed what occurred during troubleshooting by the service representative.The complaint description that sorin group (b)(4) received was that the sorin heater-cooler system 3t displayed multiple error messages during a procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.During the investigation, the service representative found that the cooling coil on the patient side was punctured and liquid had damaged the compressor, which caused one of the reported error codes.The unit was requested for further investigation into the root cause of the other reported error code, but due to export restrictions in (b)(6), the unit could not be returned and no further investigation could be performed.The damaged unit has been replaced.A review of the dhr could not identify any concessions, deviations or non-conformities relevant to the reported failure.No trend was identified for this type of issue.Sorin group (b)(4) will continue to monitor the market for trends related to this type of issue.Evaluated on site by sorin service rep.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindbergh strasse 25; munchen 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w 56th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5025623
• MDR Text Key: 24798249
• Report Number: 9611109-2015-00300
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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