MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND XTRA EQUIPMENT; APPARATUS, AUTOTRANSFUSION

Model Number 75221

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the xtra machine.The issue occurred in (b)(6).This report is filed on behalf of sorin group (b)(4).Sorin group received a report that samples taken from blood processed using an xtra autotransfusion device showed hemolysis.

Event Description

Sorin received a report that samples taken from processed blood showed hemolysis.There was no report of patient injury.

Manufacturer Narrative

Date of event" on initial report should have been (b)(6) 2015."date of this report" on initial report should have been 8/4/2015."date received by manufacturer" on initial report should have been 8/4/2015.

Manufacturer Narrative

Sorin group (b)(4) manufactures the xtra machine.The issue occurred in (b)(6).This report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that samples taken from blood processed using an xtra autotransfusion device showed hemolysis.There was no report of patient injury.A report against the disposable was filed under medwatch number 9611109- 2015-00414.The device was not returned to sorin group for investigation, but an investigation was performed by the customer.Follow-up communication with the customer has revealed that the reported issue was unrelated to the xtra autotransfusion device and the disposable.A pathologist analyzed the cell savor blood and was able to rule out any issues with the blood.After a full investigation, the facility concluded that the issue experienced by the patient was not related to cell salvage.No further investigation is requiered as there is no indication that this issue was related to cell salvage.A review of the dhr was unable to 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 issue.

• Brand Name: XTRA EQUIPMENT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; d 80939 munich, ; GM
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5089545
• MDR Text Key: 26234099
• Report Number: 9611109-2015-00383
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75221
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1