MAUDE Adverse Event Report: SORIN GROUP ITALIA APEX HP M.P.H.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050554

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 04/29/2015

Event Type  malfunction  

Event Description

The sorin group rec'd a report that blood was noticed in the heater cooler water lines of the oxygenator near the end of bypass.There was no pt injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the apex hp m.P.H.I.S.I.O.Adult hollow fiber membrane oxygenator.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group rec'd a report that blood was noticed in the heater cooler water lines of the oxygenator near the end of bypass.There was no pt injury.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

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).Sorin group received a report that blood was noticed in the heater cooler water lines of the oxygenator near the end of bypass.Visual inspection did not reveal any abnormalities.Results of leak testing showed that there was communication between the water side and blood side of the oxygenator.The heat exchanger was removed from the oxygenator module and a hole was found in the stainless steel sheet.This type of defect has been shown to be caused by corrosion from priming solution in an area of stress generated by the manufacturing process.The stressed area is caused by the presence of foreign particles in the metal sheet that can occur during manufacturing, damaging the metal sheet.A capa was implemented to address the issue.The corrective action introduced a hydrokinetic washing process to remove the presence of foreign particles on the metal sheet.The issue will be monitored for efficacy of the corrective action.

• Brand Name: APEX HP M.P.H.I.S.I.O. 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, mgr, qa ; 3034676527
• MDR Report Key: 4811732
• MDR Text Key: 20120884
• Report Number: 9680841-2015-00154
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 050554
• Device Lot Number: 1501130058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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