MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. XTRA AUTOTRANSFUSION SYSTEM, BOWL SET X/175; APPARATUS, AUTOTRANSFUSION

Model Number BOWL SET X/175

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Sepsis (2067)

Event Date 12/25/2017

Event Type  Injury  

Manufacturer Narrative

The age of the device was calculated as the time elapsed between the device sterilization and the date of the event.Importer ((b)(4)) registration number: (b)(4), manufacturer (sorin group (b)(4)) registration number: (b)(4).Sorin group (b)(4) manufactures the xtra autotransfusion system, bowl set x/175.The incident occurred in (b)(6).Per exemption number (b)(4), sorin group (b)(4).Is submitting the report for both sorin group (b)(4) (manufacturer) and (b)(4).(importer).A review of the device history record for the involved device lot confirmed that the product was released in compliance with manufacturer specifications.The involved device has been declared to be unavailable for investigation.Sorin group (b)(4) has requested additional information to clarify the potential relationship between the involved device and the patient injury.Based of the information that has been provided, it is unknown at this time if there is a relationship between the device failure and the reported patient injury.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available for return.

Event Description

Sorin group (b)(4) received a report that a leak from the bowl of an xtra autotransfusion set occurred during blood collection from surgical field.The surgical procedure was conducted due to postpartum hemorrhage.The blood collected could not be processed and the patient had to be given a bank blood transfusion.The customer later reported that the surgical procedure ended with a hysterectomy and sepsis for the patient.

• Brand Name: XTRA AUTOTRANSFUSION SYSTEM, BOWL SET X/175
• 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: 7250637
• MDR Text Key: 99301480
• Report Number: 9680841-2018-00004
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 08033178110037
• UDI-Public: (01)08033178110037(17)200917(10)1709190103
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2020
• Device Model Number: BOWL SET X/175
• Device Catalogue Number: 04252
• Device Lot Number: 1709190103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/10/2018
• Device Age: 3 MO
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• 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
• Patient Outcome(s): Other