MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008T MACHINE

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2022

Event Type  malfunction  

Event Description

A hemodialysis (hd) nurse reported a ultrafiltration (uf) issue that was occurring on unknown fresenius 2008t machines during hd treatments.Few details were obtained through follow up with a different nurse familiar with the recurring issue.It was unknown how many times it had occurred, and what machines were involved.During treatment, the uf goal on the machines was automatically resetting back to 3,000 ml and the uf time was resetting to 3 hours.It was unknown when the reset was occurring.Though specific details could not be provided, it was confirmed that no patients had any complaints or symptoms during or after their treatments.There were no adverse effects experienced, and no medical intervention was needed.The nurse did not know if any repairs were made to the machines.According to the nurse, the biomed does not come around often and works at multiple facilities.No additional information was provided.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted. .

• Brand Name: 2008T MACHINE
• Type of Device: 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: 14735445
• MDR Text Key: 302021999
• Report Number: 0002937457-2022-00987
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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