MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190610
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A third-party biomedical technician (biomed) for a hospital reported to fresenius that caster wheels on a 2008k2 machine came off or dislodged which made the machine tip over.The reported issue occurred during pretreatment setup.There was no reported patient involvement.An employee attempted to stop the fall of the machine which resulted in a shoulder injury.The employee was out from work and upon initial reporting was currently on light duty.The charge nurse reported that they will change the caster wheels on the machine to the original/smaller wheels.Additional information was provided during follow-up.The machine fell out of an elevator during transport.A nurse who was present for the fall attempted to catch the machine as it tipped over and experienced a shoulder injury.The extent of the shoulder injury was not provided.The nurse could not work for a couple of months and received rehabilitation treatment as a result of the injury.The nurse has returned to work.The third-party biomed stated that when transferring the machine for repair the machine fell again.The biomed did not attempt to catch the machine and it hit the ground pushing the acute handle through the casing.A new casing was ordered along with original wheels and all parts were replaced.The biomed confirmed that the casters on the machine at the time of the fall were a fresenius product.No parts were returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Clinical investigation: a temporal relationship exists between the transportation and tipping of a 2008k2 hemodialysis system and the serious adverse event of an unspecified shoulder injury, resulting in the nurse being unable to work 60 days and requiring rehabilitation services.While the 2008k2 hemodialysis system was not actively performing therapy while being transported, it is evident the nurse¿s injury was sustained due to an attempt to stop the machine from tipping over while the caster got caught in the elevator.The initial wheels installed on the 2008k2 machine were replaced with the fresenius acute caster kit.What remains unclear is if the inpatient wheel set-up was properly installed, as the parts were discarded, and therefore unavailable for manufacturer evaluation.Furthermore, it is unknown if the proper steps were taken while transporting the machine off the elevator.Be careful not to tip the machine when rolling over uneven surfaces.Based on the available information and the unavailability of the parts for manufacturer evaluation, the 2008k2 hemodialysis system cannot be excluded from having a possible role in the serious injury to the nurse and therefore cannot be disassociated from the reported event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A third-party biomedical technician (biomed) for a hospital reported to fresenius that caster wheels on a 2008k2 machine came off or dislodged which made the machine tip over.The reported issue occurred during pretreatment setup.There was no reported patient involvement.An employee attempted to stop the fall of the machine which resulted in a shoulder injury.The employee was out from work and upon initial reporting was currently on light duty.The charge nurse reported that they will change the caster wheels on the machine to the original/smaller wheels.Additional information was provided during follow-up.The machine fell out of an elevator during transport.A nurse who was present for the fall attempted to catch the machine as it tipped over and experienced a shoulder injury.The extent of the shoulder injury was not provided.The nurse could not work for a couple of months and received rehabilitation treatment as a result of the injury.The nurse has returned to work.The third-party biomed stated that when transferring the machine for repair the machine fell again.The biomed did not attempt to catch the machine and it hit the ground pushing the acute handle through the casing.A new casing was ordered along with original wheels and all parts were replaced.The biomed confirmed that the casters on the machine at the time of the fall were a fresenius product.No parts were returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17930241
• Report Number: 0002937457-2023-01558
• Device Sequence Number: 12362592
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K994267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown