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

Model Number CL10041021

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

A user facility reported that a crit-line blood chamber leaked a few droplets of blood during a patient¿s hemodialysis (hd) treatment.Dried blood was noted on top of the dialyzer cap at the end of a patient¿s four and a half hour treatment.The dried blood was traced to a section of the crit-line blood chamber where a crack was identified.There were no machine alarms that occurred.The patient was dialyzing on a gambro phoenix machine and utilizing a baxter revaclear max dialyzer.There was no leakage during the priming; everything had seemed normal.Blood loss was reportedly very scant, and a photo of the blood droplets on the dialyzer was provided for review.Estimated blood loss (ebl) was reported to be 0.5 ml.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.It was confirmed the patient was able to complete their treatment.The sample was reportedly available to be returned for manufacturer evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Plant investigation: the complaint sample was returned to the manufacturer for physical evaluation.The sample was not returned in its original packaging.A visual inspection was performed on the clic blood chamber, and the device was found to be acceptable with no damage observed.The sample was tested on a machine, and it worked as intended without any abnormalities.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.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.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The alleged failure could not be confirmed.

Event Description

A user facility reported that a crit-line blood chamber leaked a few droplets of blood during a patient¿s hemodialysis (hd) treatment.Dried blood was noted on top of the dialyzer cap at the end of a patient¿s four-and-a-half-hour treatment.The dried blood was traced to a section of the crit-line blood chamber where a crack was identified.There were no machine alarms that occurred.The patient was dialyzing on a gambro phoenix machine and utilizing a baxter revaclear max dialyzer.There was no leakage during the priming; everything had seemed normal.Blood loss was reportedly very scant, and a photo of the blood droplets on the dialyzer was provided for review.Estimated blood loss (ebl) was reported to be 0.5 ml.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.It was confirmed the patient was able to complete their treatment.The sample was reportedly available to be returned for manufacturer evaluation.

• Brand Name: CLIC BLOOD CHAMBER
• Type of Device: 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15547350
• MDR Text Key: 301651195
• Report Number: 0008030665-2022-01165
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861100552
• UDI-Public: 00840861100552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152953
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: CL10041021
• Device Catalogue Number: CL10041021
• Device Lot Number: 21AR01235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 104 KG