MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. XTRA COLLECTION SET; XTRA AUTOTRANSFUSION SYSTEM

Catalog Number 04260

Device Problem Inadequate Filtration Process (2308)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided.As the lot number is unknown, the expiration date and unique identifier (udi) number could not be determined.This information will be provided in a supplemental report if made available.As the lot number is unknown, the age of the device could not be determined.This information will be provided in a supplemental report if made available.(b)(4).As the lot number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Sorin group (b)(4) manufactures the xtra collection set tx.The incident occurred in (b)(6).(b)(4).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not returned.

Event Description

Sorin group (b)(4) received a report that the time required to filtrate blood during a procedure when utilizing an xtra collection set tx was too long.The customer alleged that the filtration membrane of the xtra system tank did not adapt to the volume of blood being processed.The medical team elected to administer a plasma-expander to the patient.There was no report of patient injury.

Manufacturer Narrative

Sorin group italia manufactures the xtra collection set tx.The incident occurred in bordeaux, france.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved collection reservoir was disposed of by the customer and no product traceability was provided to sorin group italia.Therefore, unit investigation and a review of manufacturing records could not be performed.No device malfunction could be confirmed.The exact root cause could not be determined.However, sorin group italia believes that the most probable root cause of the reported issue is multi-factorial and includes use conditions, clinical procedure therapies (e.G.Anticoagulant prescription, heparin composition and priming composition) and patient specific health conditions.In agreement with the customer, a training meeting has been planned at customer site.Sorin group italia will keep monitoring the market for similar events.Device disposed of by customer.

• Brand Name: XTRA COLLECTION SET
• Type of Device: XTRA AUTOTRANSFUSION SYSTEM
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7641032
• MDR Text Key: 112850924
• Report Number: 9680841-2018-00015
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K101586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04260
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2018
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR