Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP USA CONNECTOR, 1/4" X 1/4" STRAIGHT WITH LUER LOCK PORT; CARDIOVASCULAR PROCEDURE KIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SORIN GROUP USA CONNECTOR, 1/4" X 1/4" STRAIGHT WITH LUER LOCK PORT; CARDIOVASCULAR PROCEDURE KIT Back to Search Results
Catalog Number 401561000
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 02/24/2016
Event Type  malfunction  
Manufacturer Narrative
Sorin group received a report that a leak was found in the tubing pack during set-up of the heart-lung machine.The source of the leak was found to be a cracked female leur of a 1/4 x 1/4 straight connector.There was no report of patient injury.On (b)(6) 2016, sorin group received a user medwatch report ((b)(4)) regarding this issue.This report is being filed in response to this action.The received user report was filed against the custom perfusion pack, however this report is being filed against the straight tubing connector that caused the leak.Three connectors with lines attached were returned to sorin group usa for evaluation.Visual inspection of the returned devices found that one of the straight connectors had a cracked female luer.A leak test was performed and the unit was found to leak.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group received a report that a leak was found in the tubing pack during set-up of the heart-lung machine.The source of the leak was found to be a cracked female leur of a 1/4 x 1/4 straight connector.There was no report of patient injury.On (b)(6) 2016, sorin group received a user medwatch report ((b)(4)) regarding this issue.This report is being filed in response to this action.
 
Manufacturer Narrative
Initially, the 510k number for this connector could not be identified.During the investigation the connector part number was confirmed and the appropriate 510k was determined to be k981613.Sorin group received a report that a leak was found in the tubing pack during set-up of the heart-lung machine.The source of the leak was found to be a cracked female leur of a 1/4 x 1/4 straight connector.There was no report of patient injury.On april 1, 2016, sorin group received a user medwatch report ((b)(4)) regarding this issue.This report is being filed in response to this action.The received user report was filed against the custom perfusion pack, however this report is filed against the straight tubing connector that caused the leak.Evaluation at sorin group usa confirmed the crack and leak.The crack on the female luer suggests over-tightening of the connector.The heart-lung manufacturing operating procedure for twist connections specifies the amount of torque needed to attach the male cap to the female luer, so that over-tightening does not occur.The ifu indicates "make sure that the connections are secure.Do not over-tighten.' a manufactuing awareness notification was issued to the workforce responsible for assembling this product.A total of (b)(4) packs were built with this lot number and this is the only report received against the lot.Additionally, there have been no other complaints registered for this catalog number regarding cracks and leaks.No trends were identified for this issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONNECTOR, 1/4" X 1/4" STRAIGHT WITH LUER LOCK PORT
Type of Device
CARDIOVASCULAR PROCEDURE KIT
Manufacturer (Section D)
SORIN GROUP USA
14401 w. 65th way
arvada CO 80004
Manufacturer (Section G)
SORIN GROUP USA
14401 w. 65th way
arvada CO 80004
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5610112
MDR Text Key43718623
Report Number1718850-2016-00228
Device Sequence Number1
Product Code OEZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2017
Device Catalogue Number401561000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
Patient Weight68
-
-