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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility nurse reported that an external blood leak occurred two hours into a patient¿s hemodialysis (hd) treatment.It was initially reported that ¿a crack¿ was found on the clic blood chamber.Upon follow-up, it was reported that a couple of blood droplets were identified on the hd machine which were traced to an external leak from the dialyzer end connection of the clic blood chamber.An external blood leak was alleged.Reportedly, the patient¿s blood had sealed itself off at the site of the leak.As a result, the treatment was continued and completed with the same supplies and on the same machine.Despite the initial allegation of physical damage, follow-up confirmed that no cracks were visually identified on the clic blood chamber.There were no machine alarms associated with the reported failure.The patient¿s estimated blood loss (ebl) was 5 ml.There was no report of any patient adverse effects or required medical intervention.As a prophylactic measure, the patient was administered an antibiotic infusion x1 (further details on this were not provided).The clic blood chamber was not available to be returned for physical evaluation.However, a photo of the device connected to the dialyzer was provided for review.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.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.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Event or Problem Description
A user facility nurse reported that an external blood leak occurred two hours into a patient¿s hemodialysis (hd) treatment.It was initially reported that ¿a crack¿ was found on the clic blood chamber.Upon follow-up, it was reported that a couple of blood droplets were identified on the hd machine which were traced to an external leak from the dialyzer end connection of the clic blood chamber.An external blood leak was alleged.Reportedly, the patient¿s blood had sealed itself off at the site of the leak.As a result, the treatment was continued and completed with the same supplies and on the same machine.Despite the initial allegation of physical damage, follow-up confirmed that no cracks were visually identified on the clic blood chamber.There were no machine alarms associated with the reported failure.The patient¿s estimated blood loss (ebl) was 5 ml.There was no report of any patient adverse effects or required medical intervention.As a prophylactic measure, the patient was administered an antibiotic infusion x1 (further details on this were not provided).The clic blood chamber was not available to be returned for physical evaluation.However, a photo of the device connected to the dialyzer was provided for review.

• 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; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12913694
• Report Number: 8030665-2021-01811
• Device Sequence Number: 11998493
• Product Code: KOC
• UDI-Device Identifier: 00840861100552
• UDI-Public: 00840861100552
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141281
• 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): 12/28/2021

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: 03/31/2024
• Device Model Number: CL10041021
• Device Catalogue Number: CL10041021
• Device Lot Number: 21CR01024
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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 F3 DIALYZER; FRESENIUS F3 DIALYZER
• Patient Age: 10 MO
• Patient Sex: Male
• Patient Weight: 9 KG