MAUDE Adverse Event Report: SORIN GROUP ITALIA D901 LILLIPUT OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 05319

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.The expiration date refers to the sterile finished product.The complained d901 dideco lilliput phisio oxygenator (catalog number 05319, lot 2011090114) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 05319 is similar to the complained d901 dideco lilliput phisio oxygenator item 05316, which is distributed in the usa, for which the device identifier is (b)(4).The product item 05319 is not distributed in the usa, but it is similar to the d901 dideco lilliput phisio oxygenator item 05316, which is distributed in the usa (510(k) number: k953835).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the d901 dideco lilliput phisio oxygenator.The incident occurred in (b)(6).The involved device has not been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that, during a procedure, the d901 dideco lilliput phisio oxygenator was leaking.Medical team elected to change-out the oxygenator.There is no report of any patient injury.

• Brand Name: D901 LILLIPUT OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• MDR Report Key: 12621912
• MDR Text Key: 282848638
• Report Number: 9680841-2021-00027
• Device Sequence Number: 1
• Product Code: DTZ
• 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
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Catalogue Number: 05319
• Device Lot Number: 2011090114
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1