MAUDE Adverse Event Report: BECTON, DICKINSON & CO. SERO-FUGE 2001 CENTRIFUGE 1 SPEED WITH 12-PLACE HEAD; SERO-FUGE¿ 2001 CENTRIFUGE

Catalog Number 420351

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

The sero-fuge 2001 is a centrifuge designed for use in blood banks and clinical laboratories.The operator's manual indicates that to avoid physical injury, the customer should not 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 received the customer-returned centrifuge and observed the follow.The return spring in the lid latch mechanism was broken and prevented the lid latch from returning to its open position when the lid was raised.This effectively kept the lid switch closed and allowed the centrifuge to spin while the lid was in the open position.The return spring showed some corrosion which may have contributed to the breakage.There was evidence of a sample spill in or near the centrifuge.It was also observed that the latch hook was rubbing against the latch bracket causing a deep groove in the latch housing.This may have been due to a misaligned lid hinge which had evidence of being repaired and/or adjusted by the customer site.Per the serofuge user manual page 22 under the heading of to avoid physical injury states: ¿ never attempt to operate the centrifuge with the lid safety latch not functioning properly.¿ never attempt to open the centrifuge lid while the rotor is spinning.¿ test lid seal integrity by inserting a.005¿ feeler gauge between the open lid and bowl gasket.With the lid closed and latched a slight drag or resistance should be felt when pulling the feeler gauge from last the lid.This test should be performed along the entire perimeter of the lid to ensure a tight lid seal.Quality will continue to monitor trends and determine appropriate actions as needed.Device evaluated.

Event Description

The customer reported that the sero-fuge 2001 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 2001 CENTRIFUGE 1 SPEED WITH 12-PLACE HEAD
• Type of Device: SERO-FUGE¿ 2001 CENTRIFUGE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer Contact: carol nieto ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 7017667
• MDR Text Key: 92802508
• Report Number: 1119779-2017-00008
• 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: 11/08/2017

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: 420351
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other