MAUDE Adverse Event Report: SORIN GROUP USA, INC. STONYBROOK HSP NY NY 1; CUSTOM PERFUSION PACK

Catalog Number 044020000

Device Problems Break (1069); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2015

Event Type  Other  

Manufacturer Narrative

There was no patient involvement.Sorin group manufactures the custom perfusion pack.The arterial filter, catalog number 050527, lot#14120300090, is a component of the pack.The 510(k) number for the arterial filter is k112525.Sorin group received a report that during setup the clinician found the outlet port on the arterial filter broken.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that during setup the clinician found the outlet port on the arterial filter broken.There was no patient involvement.

Manufacturer Narrative

Sorin group received a report that during setup the clinician found the outlet port on the arterial filter broken.There was no patient involvement.The involved arterial filter with attached bypass loop was returned to sorin group usa for investigation.A visual inspection of the returned device confirmed that that outlet port was broken.The break occurred at the base of the connection between the tubing and the arterial filter outlet connector.There was no evidence of excessive solvent on the broken port.Root cause investigation has determined that this issue is most likely a result of internal stress which can be emphasized by the solvent used to bond the connection and/or the assembly process.Sorin group usa has opened a (b)(4) to address this issue.

• Brand Name: STONYBROOK HSP NY NY 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: 5088142
• MDR Text Key: 26263701
• Report Number: 1718850-2015-00343
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 044020000
• Device Lot Number: 1508200026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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