MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CLIC BLOOD CHAMBER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number	CL10041021
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility clinic manager (cm) reported to fresenius customer service that the crit-line clip (clic) blood chamber leaked during a patient's hemodialysis (hd) treatment.Additional information was provided by the cm during follow-up.The blood leak occurred approximately two hours into the patient¿s hemodialysis (hd) treatment.The patient's treatment was setup with a fresenius 2008t machine and a fresenius dialyzer.The blood leak was visually observed by a member of the dialysis unit.There was no defect or damage noted on the clic blood chamber.The patient¿s estimated blood loss (ebl) was approximately 300 ml.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.A prophylactic was administered to the patient (vancomycin, 500 mg, intravenously (iv), one time).Treatment was restarted and completed successfully on the same machine with new supplies.The complaint sample was discarded and is unavailable to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Additional Manufacturer Narrative
Correction: h6 (health effect clinical code) plant investigation: the manufacturer did not receive the complaint product sample for evaluation.However, a photograph of the alleged malfunction was received.According with the photograph a separation could be observed between the clic body and din connector.The alleged failure mode was confirmed with the photogaph received.A batch records review was conducted by the manufacturer for the reported lot.One nonconformance was found that is related to the failure mode alleged in the complaint.The nonconformance addresses a separation found between the clic body and din connector which also confirms the reported issue.This kind of failure mode could be caused from operator error, a malfunctioning dispenser, lack of solvent in dispenser, obstruction in solvent circuit, flow regulator obstructed or closed, solvent level, regulation of solvent dispensed quantity, wetting mechanic does not work, component temperature, or a gripper system malfunction.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.
Event or Problem Description
A user facility clinic manager (cm) reported to fresenius customer service that the crit-line clip (clic) blood chamber leaked during a patient's hemodialysis (hd) treatment.Additional information was provided by the cm during follow-up.The blood leak occurred approximately two hours into the patient¿s hemodialysis (hd) treatment.The patient's treatment was setup with a fresenius 2008t machine and a fresenius dialyzer.The blood leak was visually observed by a member of the dialysis unit.There was no defect or damage noted on the clic blood chamber.The patient¿s estimated blood loss (ebl) was approximately 300 ml.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.A prophylactic was administered to the patient (vancomycin, 500 mg, intravenously (iv), one time).Treatment was restarted and completed successfully on the same machine with new supplies.The complaint sample was discarded and is unavailable to be returned to the manufacturer for physical evaluation.

• Brand Name: CLIC BLOOD CHAMBER
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16994690
• Report Number: 0008030665-2023-00471
• Device Sequence Number: 19677245
• Product Code: KOC
• UDI-Device Identifier: 00840861100552
• UDI-Public: 00840861100552
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K152953
• 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): 07/06/2023

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 Expiration Date: 07/31/2024
• Device Model Number: CL10041021
• Device Catalogue Number: CL10041021
• Device Lot Number: 21JR01239
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 55 KG