MAUDE Adverse Event Report: ANDREAS HETTICH GMBH & CO. KG HETTICH; ROTANTA 460 R

Model Number ROTANTA 460 R

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

The bucket broke because of fatigue of the material.The lid of the centrifuge opened because the closure s bolt and exceriter had not yet the actual status with regard to design and material.Corrective actions: changes of the closure of the lid: 2003: steel sheet of centrifuge vessel: addition of material for protection of closure (actual status of drawing 03/10/2003) 2006: additional information printed on bucket 4412: max.Load 800g and set number (change report 0160/06).2007: bucket 4412 change of hinge design for higher stress resistance (change report 0170/07).2008: excenter changed from plastics to aluminum (change report 0377/08).2008: bolt with interruptor the prevent unwanted opening of the lid (change report 0377/08).2009: additional information on bucket 4412: number of maximal cycles (change report 0199/09).

Event Description

This is a delayed notification due to the fact that the esg account from the manufacturer was not working until now.Due to the late notification, there was no threat to patients, users and third parties.The buckets of centrifuge rotanta 460r crashed during centrifugation.Parameters unknown.Load was 2450 ml greiner tubes.During crash the centrifuge turned 90 degrees on its side, cover openend and one of the buckets went out into the wall.Bottom of bucket broke off completely from the bucket itself.There is also heavy damage to the inner parts of the centrifuge.On the bench the centrifuge was surrounded by 300 mm free from other objects according to customer information.

• Brand Name: HETTICH
• Type of Device: ROTANTA 460 R
• Manufacturer (Section D): ANDREAS HETTICH GMBH & CO. KG; fohrenstr. 12; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): ANDREAS HETTICH GMBH & CO. KG; foehrenstr. 12; tuttlingen, baden-württemberg 78532 ; GM 78532
• Manufacturer Contact: johann giebelhaus ; foehrenstr. 12; tuttlingen, baden-württemberg 78532 ; GM 78532
• MDR Report Key: 9648025
• MDR Text Key: 191919878
• Report Number: 3005990076-2020-00001
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTANTA 460 R
• Device Catalogue Number: 5605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 17 YR
• Event Location: Hospital
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2002
• 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