MAUDE Adverse Event Report: SORIN GROUP USA, INC. SOUTHLAKE HSP NEWMARKET CAN; CUSTOM PERFUSION PACK

Catalog Number 067792001

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 06/27/2014

Event Type  Other  

Event Description

Sorin group received a report that the pump header line of the customer perfusion pack began to slip off of the port of a competitor's oxygenator during a procedure.There was no report of pt injury.

Manufacturer Narrative

Sorin group received a report that the pump header line of the customer perfusion pack began to slip off of the port of a competitor's oxygenator during a procedure.There was no report of pt injury.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

• Brand Name: SOUTHLAKE HSP NEWMARKET CAN
• 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 west 65th way; arvada CO 80004
• Manufacturer Contact: cheri voorhees, mgr, quality as ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4003573
• MDR Text Key: 4709275
• Report Number: 1718850-2014-00250
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 067792001
• Device Lot Number: 1400600023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2014
• 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