MAUDE Adverse Event Report: UNKNOWN UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Patient age and weight were not provided.The date of death was not provided.This information will be provided in a supplemental report if and when made available.An event date was not provided.This information will be provided in a supplemental report if and when made available.No device information was provided in the legal complaint.This information will be provided in a supplemental report if and when made available.As no device information was provided in the legal complaint, it is unknown what type of device is under complaint.The product code selected (oez) is not confirmed.This information will be provided in a supplemental report if and when made available.As device information was not provided, the correct manufacturer could not be identified.The country selection ((b)(6)) is not confirmed.The model and serial number have not been provided and the udi could not be determined.This information will be provided in a supplemental report if and when made available.As device information was not provided, the correct manufacturer could not be identified.The country selection ((b)(6)) is not confirmed.A model number was not provided, so the 510(k) number could not be determined.The serial number was not provided, so it is unknown if the unit has already been returned or not.This information will be provided in a supplemental report if and when made available.The serial number was not provided, so the manufacture date could not be determined.This information will be provided in a supplemental report if and when made available.Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).On august 8, 2016, sorin group (b)(4) was notified of a legal complaint that was filed on (b)(6) 2016.The complaint identified a single patient from (b)(6) hospital.The patient has expired, but it is not known when the death occurred.As no additional information regarding the patient or the reason for the complaint was provided, the report could not be connected to a previous complaint received from the facility.The investigation is on-going.A supplemental report will be provided upon receipt of any additional information.

Event Description

On august 8, 2016, sorin group (b)(4) was notified of a legal complaint that was filed on (b)(6) 2016.The complaint identified a single patient from (b)(6) hospital.The patient has expired, but it is not known when the death occurred.As no additional information regarding the patient or the reason for the complaint was provided, the report could not be connected to a previous complaint received from the facility.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): UNKNOWN; unknown; unknown, UNKNO WN; GM UNKNOWN
• Manufacturer (Section G): UNKNOWN; unknown; unknown, UNKNO WN; GM UNKNOWN
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5873537
• MDR Text Key: 52058793
• Report Number: 9611109-2016-00562
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death