MAUDE Adverse Event Report: BECKMAN COULTER COULTER DH DILUENT; DILUENT, BLOOD CELL

Model Number FP,DXH DILUENT,10L

Device Problem Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported this event verbally to the local bec sales representative, who asked if the customer would provide the information in writing.The customer stated that they required surgical intervention for herniated discs at location c6 and c7 of the spine as a result of handling the 10 liter and 20 liter reagent bottles throughout the 8 years she has worked in the lab.A retrospective review of the complaint database showed no other events related to strain, sprain, or injury as a consequence of handling the diluent reagent bottles.A supplemental report will be submitted for any new information.Bec internal identifier (b)(4).

Event Description

The customer reported experiencing chronic upper back injury, which required surgical intervention, due to the handling of the dxh 800 instrument diluent bottle.The customer has been working in the hellin laboratory for the past eight years.In (b)(6) 2018, the laboratory changed their hematology instruments from the beckman lh instruments platform to beckman's dxh instruments.With the lh instruments, a diluent bottle containing 21l was used and located on the floor in the proximity of the instrument.With the dxh instruments , the laboratory uses 10l diluent bottles that require to be lifted about 60cm (near 2 feet) to the reagent tray.There was no impact to patient results as a result of this event.There was no change to patient treatment.

Manufacturer Narrative

Follow up 01: the operator has worked in the laboratory of hellín hospital for the last eight (8) years.On (b)(6) 2018, the laboratory changed the hematology instruments from the lh platform to dxh.With the lh platform, a diluent bottle containing 21l was used and was dragged along the floor to the proximity of the instrument.With the dxh platform, a diluent bottle containing 10l is used and needs to be lifted about 60cm (near 2 feet) high to the reagent tray.The diluent bottle assembled in a cardboard box weighs approximately 22 lb.There is no history of previous cases to report strain, sprain or any other injury, due to the diluent bottle weight handling.Additional information was requested and only information provided to the field service engineer (fse) was that the operator continues her rehabilitation and still on leave from work.Bec internal identifier - case-(b)(4).

Manufacturer Narrative

Follow up 02: section a patient information: there was no patient impact as a result of this event.The reported event was an allegation of an ergonomic injury of an operator as a result of lifting the diluent reagent bottles.Only the operator name was provided.Section b1 date of event has been updated with correct date.Section e1 initial reporter name and address.Reporter facility address has been added.Section g1: mdr reporting contact name and address has been updated with current contact information.Manufacturing site name and address has been updated with the correct information.Phone number has been updated with current contact information.Bec internal identifier: (b)(4).

• Brand Name: COULTER DH DILUENT
• Type of Device: DILUENT, BLOOD CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 11200890
• MDR Text Key: 230933616
• Report Number: 1061932-2019-01828
• Device Sequence Number: 1
• Product Code: GIF
• Combination Product (y/n): N
• PMA/PMN Number: K081930
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

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 Model Number: FP,DXH DILUENT,10L
• Device Catalogue Number: 628017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 12/20/2019; 01/27/2021
• Supplement Dates FDA Received: 01/20/2021; 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1