MAUDE Adverse Event Report: BD 7 LOVETON SERO-FUGE¿ 2002 CENTRIFUGE 2 SPEED WITH 12-PLACE HEAD; EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDI

Catalog Number 420352

Device Problem Device Remains Activated (1525)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

The sero-fuge¿ 2002 centrifuge is designed for use in blood bank/clinical laboratory settings to aid in simplifying basic test procedures through the use of controlled centrifugation speed.The operator's manual indicates that to avoid physical injury, the customer is never to attempt to operate the centrifuge with the lid safety latch not functioning properly nor open the centrifuge lid while the rotor is spinning.Bd quality's investigation has confirmed that the sero-fuge¿ 2002 centrifuge did continue to spin after the lid unlatched.A defective sensor responsible for the detection of the rotor rotation speed was identified as the root cause for the failure.Quality noted that once the lid unlatched, the motor's power was shut off as designed and the unit stopped spinning thereafter.Quality has reviewed complaints for the reported failure mode and no trend has been identified.

Event Description

The customer reported the serofuge centrifuge continues to spin after the lid opens.The unit was taken out of service and replaced.No injuries were reported.

• Brand Name: SERO-FUGE¿ 2002 CENTRIFUGE 2 SPEED WITH 12-PLACE HEAD
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDI
• Manufacturer (Section D): BD 7 LOVETON; 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer Contact: charlotte dannenfelser ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 5219998
• MDR Text Key: 31230143
• Report Number: 0001119779-2015-00006
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/09/2015

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 Catalogue Number: 420352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other