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

Catalog Number	CL10041001
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem 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.
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 did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.
Event or Problem 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
• Common Device Name: 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
• Report Number: 0002937457-2024-00115
• Device Sequence Number: 15723601
• Product Code: KOC
• UDI-Device Identifier: 00840861101139
• UDI-Public: 00840861101139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CL10041001
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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
• Patient Sex: Unknown