MAUDE Adverse Event Report: SORIN GROUP ITALIA APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR; OCYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050554

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

Patient Problem No Patient involvement (2648)

Event Date 09/08/2014

Event Type  Other  

Event Description

Sorin group received a report that during pre-op testing of the apex oxygenator, fluid was seen leaking from the heat exchanger.There was no pt involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the apex oxygenator.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).The returned apex oxygenator was visually inspected and no evidence of any defect was present.Leak testing was performed by pressurizing the water side and blood side of the oxygenator heat exchanger.During pressurized testing, no leaks were observed.Sorin group (b)(4) has concluded the cause of the water noted by the customer may be related to the manner in which the customer pressurized the oxygenator and then removed the water lines.Water could have been left in the oxygenator's heat exchanger and thus, the reason the residual water on the towel placed under the oxygenator by the customer after the water lines were removed and noted.The reported issue was not confirmed.Testing showed no leaks or issues with the oxygenator heat exchanger.Sorin group (b)(4) will be monitor this issue for trends and corrective action will be recommended if trends are identified.

• Brand Name: APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
• Type of Device: OCYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA; via statle 12 nord, 86; mirandola ; IT
• Manufacturer Contact: cheri coorhees, mgr, quality as ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4187579
• MDR Text Key: 5025375
• Report Number: 1718850-2014-00352
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092895
• 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: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 050554
• Device Lot Number: 1403250006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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