MAUDE Adverse Event Report: SORIN GROUP ITALIA D731 MICRO 27 PH.I.S.O. ARTERIAL FILTER; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number 050526

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

Patient Problem No Patient involvement (2648)

Event Date 05/20/2014

Event Type  Other  

Event Description

Sorin group received a report that the outlet port of the arterial filter was found broken off during the set up of the pack.A new arterial filter assembly was scavenged from a pack off of the shelf in order to be able to use this heart lung pack.There was no pt involvement.

Manufacturer Narrative

There was no pt involvement.Sorin group (b)(4) manufactures the d731 micro 27 ph.I.S.I.O.Arterial filter.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group received a report that the outlet port of the arterial life was found broken off during the set up of the pack.A new arterial filter assembly was scavenged from a pack off of the shelf in order to be able to use this heart lung pack.There was no pt involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

• Brand Name: D731 MICRO 27 PH.I.S.O. ARTERIAL FILTER
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• 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 ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3894229
• MDR Text Key: 16547407
• Report Number: 1718850-2014-00199
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112525
• 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: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 050526
• Device Lot Number: 1401210072
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/16/2014
• Date Device Manufactured: 01/01/2014
• 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