MAUDE Adverse Event Report: SORIN GROUP ITALIA DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Catalog Number 04051

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2014

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that the filter became detached from the autotransfusion cardiotomy reservoir during a procedure.There was no report of pt injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the dideco ats autotransfusion cardiotomy reservoir.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the filter became detached from the autotransfusion cardiotomy reservoir during a procedure.There was no report of pt injury.The unit was discarded by the hospital and therefore, no eval could be performed to confirm the report.However, based on previous cases with a similar description, it was determined that a blow to the reservoir lid could cause the connector, which joins the filter to the reservoir lid, to crack and lead to a filter detachment.It is likely the reported issue was caused by a crack in the connector due to a mechanical force.Sorin group has implemented corrective and preventative actions to strengthen this specific area of the reservoir.The coupling system between the reservoir top lid and the upper part of the internal filter has been strengthened.Additionally, a rib was added to the vacuum port to add add'l strength to this portion of the reservoir.The reservoir was manufactured after these corrective actions were implemented.These corrective actions have reduced the number of these complaints although these types of complaints will continue to be monitored.

• Brand Name: DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
• Type of Device: RESERVOIR, BLOOD, 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. ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3803006
• MDR Text Key: 4384659
• Report Number: 1718850-2014-00129
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K992599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 04051
• Device Lot Number: 1310220088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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