MAUDE Adverse Event Report: SORIN GROUP ITALIA SYNTHESIS P.H.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050234

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 06/02/2014

Event Type  Other  

Event Description

Sorin group received a report that the clinician noted that the water in the heater/cooler had a pink tinge to it during tear down of the circuit upon completion of the procedure.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the synthesis p.H.I.S.I.O.Adult membrane oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir.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 clinician noted that the water in the heater/cooler had a pink tinge to it during tear down of the circuit upon completion of the procedure.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: SYNTHESIS P.H.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• 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, mgr. ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3902381
• MDR Text Key: 4541579
• Report Number: 1718850-2014-00191
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073380
• 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: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 050234
• Device Lot Number: 1402110125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: 44 YR
• Patient Weight: 94