MAUDE Adverse Event Report: ALIFAX S.P.A TEST1 BCL ANALYSER

Catalog Number A41376

Device Problem Positioning Problem (3009)

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

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

The customer reported that an instrument mechanical arm had come out from the test1 bcl analyzer.The field service engineer, fse, observed that the mechanical stoop in the arm was broken.The complete arm was replaced in order to resolve the issue.The customer was also informed that the instrument is not to be handled or used in that condition and that they need to call as soon as the issue is identified.The instrument involved in this event is manufactured by alifax, (b)(4) is the distributor and importer to the us.Alifax was notified of the event.Investigation, risk assessment, and corrective actions are all initiated by the manufacturer.Per medical device reporting (mdr) regulation (21 cfr 803), importers are required to report to the fda when they learn that one of their devices may have caused or contributed to a death or serious injury.Therefore as the importer of this device, (b)(4), deemed this event reportable labeling: alifax test 1 operator manual doc.No.D195.07.01-uk-rev.1.1 (last revision 24-06-2008) states, on page 7, that "for your safety, if any parts are damaged, ask for immediate replacing with original spare parts".This statement is in both the english and spanish version of the operator's manual.

Event Description

The customer reported that an instrument mechanical arm had come out from the test1 bcl analyzer.An operator attempted to put the arm back in place and was cut on the hand by the frame.A second operator attempted to repair the instrument and received a small cut as well.This event does not involve patient results or change in patient treatment.The operators were wearing personal protective equipment (ppe) consisting of nitrile gloves at the time of the event.The customer indicated that injury took place while handling the bearing area.The operators were not in direct contact with a contaminated area.On (b)(6) 2017, an operator attempted to put the arm back in place and was cut on the hand by the frame.The cut was located on the thumb of the right hand, near the end of the nail and approximately 7 mm in length.The injury required the application of steri-strips (3) and the administration of a tetanus vaccination.Blood work was also done for baseline testing.On (b)(6) 2017, a second operator attempted to repair the instrument and received a small cut.The second operator suffered only a superficial wound, and medical intervention was not required.All actions were taken according to the steps indicated by the customer's occupational risk service.

• Brand Name: TEST1 BCL ANALYSER
• Type of Device: TEST1 BCL ANALYSER
• Manufacturer (Section D): ALIFAX S.P.A; via franceso petrarca; 35020 polverara; padova ; IT
• MDR Report Key: 6640482
• MDR Text Key: 77554728
• Report Number: 2023446-2017-00003
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/22/2017,05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A41376
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention