MAUDE Adverse Event Report: SORIN GROUP USA, INC. CHILDREN'S HSP BOST MA 1; CUSTOM PERFUSION PACK

Catalog Number 6277286402

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

Patient Problem Death (1802)

Event Type  Death  

Event Description

Sorin group received a report that the pt expired.Autopsy of the pt revealed hemolysis, although it is unk if a sorin group product contributed to the event.

Manufacturer Narrative

The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that the patient expired.Autopsy of the patient revealed hemolysis, although it is unknown if a sorin group product contributed to the event.Continued communications with the customer revealed that there was no allegation by the customer that any device or product in the sorin heart lung pack contributed to the death.They said that they have seen hemolysis on a couple of the other patients.No product will be returned and without a specific lot number for review, no device history record could be identified for review.Since no failure or defect of any sorin product has been identified and there is no trend for this type of issue, no action is deemed necessary at this time.

• Brand Name: CHILDREN'S HSP BOST MA 1
• Type of Device: CUSTOM PERFUSION PACK
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4254694
• MDR Text Key: 20661765
• Report Number: 1718850-2014-00403
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6277286402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death