MAUDE Adverse Event Report: CONCORD MANUFACTURING CRIT-LINE CLIP (CLIC) - USB; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number CL10041001

Device Problem Inaccurate Information (4051)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility registered nurse (rn) reported to fresenius that the crit-line clip (clic) device provided inaccurate (low) hematocrit (hct) and hemoglobin (hgb) readings during a patient's hemodialysis (hd) treatment.The clic device was started correctly by staff and the initial readings were reported to be 15.9 hct and 5.4 hgb.Approximately two hours into treatment the readings were retaken and provided as 17.3 hct and 5.9 hgb.The patient's blood was manually drawn and tested and revealed that the patient's hgb was 9.0.The patient did not experience a serious injury nor require medical intervention.The patient's estimated blood loss (ebl) was approximately 5 ml.It was indicated upon initial reporting that the patient was able to complete treatment on the day of the event.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.

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 did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.

Event Description

A user facility registered nurse (rn) reported to fresenius that the crit-line clip (clic) device provided inaccurate (low) hematocrit (hct) and hemoglobin (hgb) readings during a patient's hemodialysis (hd) treatment.The clic device was started correctly by staff and the initial readings were reported to be 15.9 hct and 5.4 hgb.Approximately two hours into treatment the readings were retaken and provided as 17.3 hct and 5.9 hgb.The patient's blood was manually drawn and tested and revealed that the patient's hgb was 9.0.The patient did not experience a serious injury nor require medical intervention.The patient's estimated blood loss (ebl) was approximately 5 ml.It was indicated upon initial reporting that the patient was able to complete treatment on the day of the event.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.

• Brand Name: CRIT-LINE CLIP (CLIC) - USB
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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: 18546439
• MDR Text Key: 333279901
• Report Number: 0002937457-2024-00115
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CL10041001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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