MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION

Model Number APTIO AUTOMATION

Device Problem Use of Device Problem (1670)

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

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

An instrument operator was exposed to a hot surface while performing maintenance on the tube sealer module of an aptio automation system.A siemens customer service engineer (cse) was dispatched to inspect the instrument.The cse did not find an instrument malfunction.It is unknown if the operator followed the maintenance instructions in the operator's guide to remove all sample tubes from the area and wait approximately 30 minutes for the sealing head to cool before performing maintenance.The instrument is performing within specifications.No further evaluation of this device is needed.

Event Description

An instrument operator was exposed to a hot surface while performing maintenance on the tube sealer module of an aptio automation system.The operator reportedly had their thumb get caught in the hot sealer head.The safety shield was up on the sealer module.The operator went to the emergency department.The emergency department reported the skin on the thumb was not broken, did not bleed and there appeared to be no damage to the thumb.There are no known reports of patient intervention or adverse health consequences due to the heat exposure from the sealer module.

• Brand Name: APTIO AUTOMATION
• Type of Device: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): INPECO S.P.A; via torraccia 26; registration #: 3010825766; novazzano, 6883 ; SZ 6883
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 9369135
• MDR Text Key: 191029870
• Report Number: 2517506-2019-00441
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

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 Model Number: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: No
• 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