MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL XTRA AUTOTRANSFUSION SYSTEM; APPARATUS, AUTOTRANSFUSION

Catalog Number 04255J

Device Problem Sharp Edges (4013)

Patient Problem Skin Tears (2516)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.The product item 04255j - procedure set tx/125 is not distributed in the usa and it is similar item 04255.The expiry date refers to the sterile finished product.The complained product item 04255j - procedure set tx/125 is not distributed in the usa, therefore the udi is not applicable.The product item 04255j - procedure set tx/125 is similar to the 04255, which is distributed in the usa, for which the device identifier is (b)(4).The product item 04255j - procedure set tx/125 is not distributed in the usa, but it is similar to the item 04255 - procedure set tx/125, which is distributed in the usa (510(k) number: k101586).The device manufacture date refers to manufacture date of the sterile, finished procedure set tx/125.Sorin group (b)(4) manufactures the procedure set tx/125.The incident occurred in (b)(6).The device has been requested for investigation and not yet received.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that, during setting the wash set procedure set tx/125, while attempting to spike the washing line into the saline pack, the glove and finger-skin of the health operator got hurt with the corners.The customer felt that the corner part was sharper than in a other product of the same catalogue.

Event Description

See intial report.

Manufacturer Narrative

Livanova received report stating that, when inserting the terminal needle of wash line to the saline bag for setup of bowl set, operator cut his finger with the edge of the corner part.Visual inspection of the returned spike needles found neither any material integrity problem nor any cutting edges (no sharp point nor burr).Verification of manufacturing records confirmed that claimed device was released conforming to product specifications.Analysis of complaints database revealed no other similar event relevant to the complained lot.Based on investigation results, no direct relationship between user hurt and any material non-conformity was established.A possible root cause of reported event was a rough handling by operator.Since no device malfunction could be confirmed, no action was deemed necessary.Livanova will maintain monitoring the market.

• Brand Name: XTRA AUTOTRANSFUSION SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• MDR Report Key: 12259322
• MDR Text Key: 264513134
• Report Number: 9680841-2021-00021
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2023
• Device Catalogue Number: 04255J
• Device Lot Number: 2010290094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1