MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/225; APPARATUS, AUTOTRANSFUSION

Catalog Number 04264

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The age of the device was calculated as the time elapsed between the device sterilization and the date of the event.(b)(4).Sorin group (b)(4) manufactures the xtra autotransfusion system, procedure set bx/225.The incident occurred in (b)(6).(b)(4).The failed connection was a connection made by the user during set-up of the device on the autotransfusion equipment.Sorin group (b)(4) has determined that this issue was caused by user error.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device not available for return.

Event Description

Sorin group (b)(6) received a report that the blue tubing from the xtra procedure set disconnected from the reservoir during a case and blood spilled on floor and doctor.The tubing was reconnected and the procedure was completed without further issue.There was no patient injury, and no injury was reported for the doctor.

• Brand Name: XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/225
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (modena) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6459594
• MDR Text Key: 71742090
• Report Number: 9680841-2017-00011
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 08033178110808
• UDI-Public: (01)08033178110808(17)191114(10)1611140164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Catalogue Number: 04264
• Device Lot Number: 1611140164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/07/2017
• Device Age: 4 MO
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1