MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191130

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that the blood pump rotor tubing guide roller on a 2008t machine came loose during a patient's hemodialysis (hd) treatment and damaged the bloodline tubing (brand unknown) resulting in a blood leak.The biomed could not confirm whether the machine provided any diagnostic message or alarms in response to the reported issue.It was reported that the setup was changed (machine and supplies disposition unknown) and that the patient was able to complete treatment without experiencing a serious injury or requiring medical intervention.The patient's estimated blood loss was not reported.Fresenius technical services explained to the biomed that the part could be replaced under warranty.Additional information was requested however a response was not received.The sample was returned to the manufacturer for physical evaluation.

Manufacturer Narrative

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

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that the blood pump rotor tubing guide roller on a 2008t machine came loose during a patient's hemodialysis (hd) treatment and damaged the bloodline tubing (brand unknown) resulting in a blood leak.The biomed could not confirm whether the machine provided any diagnostic message or alarms in response to the reported issue.It was reported that the setup was changed (machine and supplies disposition unknown) and that the patient was able to complete treatment without experiencing a serious injury or requiring medical intervention.The patient's estimated blood loss was not reported.Fresenius technical services explained to the biomed that the part could be replaced under warranty.Additional information was requested however a response was not received.The sample was returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: h3 plant investigation: eight blood pump rotors were returned to the manufacturer under the return goods authorization (rga) number assigned to this case file.None of the returned rotors are identified as belonging to a specific complaint or machine serial number.The evaluation of all eight samples has been captured within this investigation.During a visual inspection it was noted that five samples had loose and deformed sleeves over their guide pins, two samples were missing sleeves, and one sample had a damaged sleeve.The samples were tested with a bloodline and water on a blood pump module of a test machine at a rate of 450 ml/min.None of the rotors damaged the bloodline and no leaks occurred.The sleeve remained intact and no further damage was done to the rotor during testing.The reported fluid leaks could not be confirmed as they could not be duplicated during testing.However the reported physical damage has been confirmed.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were two approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The investigation into the complaint was able to confirm the reported event.

• Brand Name: 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
• 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: 15660954
• MDR Text Key: 306912431
• Report Number: 0002937457-2022-01771
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 191130
• Device Catalogue Number: 191130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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