MAUDE Adverse Event Report: SORIN GROUP ITALIA PRIMO2X ADULT HOLLOW FIBER MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050528

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2018

Event Type  Other  

Event Description

Sorin group received a report that the blood in the primo2x oxygenator was dark after going back onto bypass.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the primo2x adult hollow fiber membrane oxygenator.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group received a report that the blood in the primo2x oxygenator was dark after going back onto bypass.There was no report of patient injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

• Brand Name: PRIMO2X ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola ; IT
• Manufacturer Contact: cheri voorhees, manager ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3955645
• MDR Text Key: 19297813
• Report Number: 1718850-2014-00230
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 050528
• Device Lot Number: 1312030023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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 Age: 73 YR
• Patient Weight: 109