MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 471 CENTRIFUGE UNIT; AUTOMATED CENTRIFUGE UNIT

Catalog Number 07962584001

Device Problem Protective Measures Problem (3015)

Patient Problem Laceration(s) (1946)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

The investigation did not identify a product issue.Medwatch field e1 facility name - the full facility name was provided as "drk-blutspendedienst ggmbh baden-württemberg-hessen institute frankfurt/main inst.Für transfusionsmedizn".

Event Description

It was reported that a roche service technician hit his head on a cobas p 471 centrifuge unit while repairing it.The technician reportedly sustained a laceration.The laceration was reported to be closed with staples while the technician was in an ambulance.It was reported that no subsequent complications were observed for the technician.Further information regarding the circumstances of the incident was requested but not provided.

Manufacturer Narrative

It has been determined that the system was not turned off at the time the event occurred.The operators put magnets on the door to keep the system in operation with the doors open.Investigations determined there was no malfunction of the device.

Manufacturer Narrative

The component code has been updated.

Manufacturer Narrative

H6 investigation findings codes and investigation conclusion codes were updated.

• Brand Name: COBAS P 471 CENTRIFUGE UNIT
• Type of Device: AUTOMATED CENTRIFUGE UNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH; maybachstrasse 30; waiblingen (baden-wurttemberg) 71332 ; GM 71332
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18591709
• MDR Text Key: 333898239
• Report Number: 1823260-2024-00238
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2024

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: 07962584001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 03/07/2024; 03/27/2024; 05/02/2024
• Supplement Dates FDA Received: 03/08/2024; 04/09/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1