MAUDE Adverse Event Report: ANDREAS HETTICH GMBH & CO. KG HETTICH; EBA 21

Model Number EBA 21

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

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

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

The centrifuge was running at just under 12,000 rcf for approximately 1 min.When the holder of the plastic lid of the rotor broke causing the plastic lid to come off the rotor.The user intended to switch off the centrifuge.However she accidentally used the lid open knob.She managed to open the lid of the centrifuge while the rotor was still turning.The detached plastic lid of the rotor flew out of the centrifuge.If the closure of the centrifuge worked correctly she should not have been able to open the centrifuge lid despite of turning the lid open knob in the "lid open" direction.

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 centrifuge was running at just under 12,000 rcf for approximately 1 min.When the holder of the plastic lid of the rotor broke causing the plastic lid to come off the rotor.The user intended to switch off the centrifuge.However she accidentally used the lid open knob.She managed to open the lid of the centrifuge while the rotor was still turning.The detached plastic lid of the rotor flew out of the centrifuge.If the closure of the centrifuge worked correctly she should not have been able to open the centrifuge lid despite of turning the lid open knob in the "lid open" direction.

• Brand Name: HETTICH
• Type of Device: EBA 21
• Manufacturer (Section D): ANDREAS HETTICH GMBH & CO. KG; foehrenstr. 12; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• Manufacturer (Section G): ANDREAS HETTICH GMBH & CO. KG; foehrenstr. 12; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• Manufacturer Contact: johann giebelhaus ; foehrenstr. 12; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• MDR Report Key: 9647956
• MDR Text Key: 191919871
• Report Number: 3005990076-2020-00002
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/10/2018,01/30/2020

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: EBA 21
• Device Catalogue Number: 1004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 12/10/2018
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2014
• 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