MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problem Fluid Leak (1250)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

The facility administrator (fa) from a hemodialysis (hd) clinic reported that the blood pump rotor tubing guide broke on a fresenius 2008t machine and sliced the blood tubing causing it to leak. Upon follow-up, it was reported that this occurred twice on the same machine, but with separate patients. Each time, the blood pump rotor cut the bloodline tubing approximately one to two hours into hd treatment. The fa stated the blood pump rotor was chafing the tubing and eventually cut through it. Both patients were able to complete their treatment on the machine after being re-setup with new supplies. The fa stated the estimated blood loss (ebl) was 100 ml for each event. Per the fa, the operator had noticed a small amount of blood dripping onto the floor, which alerted them to the issue. The fa stated this was a machine issue, and confirmed that there was nothing wrong with the bloodlines. There were no machine alarms, but none were expected. The fa stated that blood was being pushed out, through the sliced tubing. There were no air detector alarms because ¿no air was being sucked in¿ [sic]. Following the first event, the facility continued using the machine not knowing the blood pump rotor was damaged. However, the same thing happened with the next patient who dialyzed on the machine. After the second blood leak event, further investigation revealed that the blood pump rotor tubing guide broke and sliced the bloodline tubing. It was reported that the facility purchases their blood pump rotors from a third-party vendor (gia medical). The fa stated the blood pump rotor was replaced and this resolved the reported issue. Other than blood loss, it was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported events. The fa declined to provide any patient information. No sample was available to be returned for evaluation as the damaged rotor was discarded. This report captures the second event.

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14246989
• MDR Text Key: 290454194
• Report Number: 0002937457-2022-00703
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse