MAUDE Adverse Event Report: THERMO FLECTRON INDUSTRIES SAS JOUAN CENTRIFUGE

Catalog Number 11177561

Device Problem Device Inoperable (1663)

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

Event Date 12/18/2013

Event Type  malfunction  

Event Description

Bd applications specialists contacted bd technical service and support and reported that the lid hydraulics are not working and the lid will not stay up on the customers centrifuge.The customer reported that the lid has hit one tech in the head and another on the hand.The customer stated that no one has had to seek medical attention due to the lid falling down.

Manufacturer Narrative

Bd was unable to confirm the complaint on the customers returned centrifuge.Unit was received at the bd (b)(4) facility and upon further eval on the centrifuge unit, the lid on the unit would not open at all.The most likely cause for lid not holding up and falling down, is that gas springs most likely had worn out and are not functioning as intended.However, based on the gas springs manufacturer "aegis hahn-gas springs" the life expectancy for the gas springs, dampers are (10,000 cycles), tension springs (2,000 cycles) locking springs (4,000 cycles), if used in indoor, non-corrosive conditions.Based on the previous info we concluded that life expectancy of the gas springs for the unit under question has already reached/passed life expectancy, which triggered the gas springs to malfunction.However, the failure mode described by customer was not confirmed as the unit would not open at all for any testing.A review of the centrifuge lid falling down complaints was performed and the data does not indicate an increase in the number of events.Bd will continue to monitor for trends.The device manufacturer will be notified of the event.

• Brand Name: JOUAN CENTRIFUGE
• Type of Device: CENTRIFUGE
• Manufacturer (Section D): THERMO FLECTRON INDUSTRIES SAS; chateau-gontier ; FR
• Manufacturer (Section G): THERMO ELECTRON INDUSTRIES SAS; zi aze bellltourne; chateau-gontier 5320 0; FR 53200
• Manufacturer Contact: charlotte dannenfelser ; 7 loveton cir.; sparks, MD 21152 ; 4103164367
• MDR Report Key: 3644787
• MDR Text Key: 4348614
• Report Number: 1119779-2014-00003
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 11177561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• 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): Required Intervention