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 06/24/2022

Event Type  malfunction  

Event Description

A user facility reported to fresenius via voluntary medwatch # (b)(4) that a blood leak occurred with a crit-line clip (clic) blood chamber during a patient¿s hemodialysis (hd) treatment.The blood leak was caught immediately by the staff.The machine, a fresenius 2008t hd system, did not alarm.It was reported that the clic blood chamber separated into two parts.The blue sensor disconnected from the part that connects with the dialyzer.The patient was utilizing a fresenius dialyzer and fresenius bloodlines.It was confirmed that the dialyzer and bloodlines had not malfunctioned in any way.There was no defect or damage seen on the clic blood chamber prior to the event.There were no loose connections or issues encountered during prime.The patient¿s estimated blood loss (ebl) was approximately 250 ml.It was confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on the same machine and treatment was completed successfully with new supplies.The sample was available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received and a physical evaluation could not be performed.However, a photograph was received from the customer which shows a separation from the blue chamber body connection to the din connector.This kind of failure mode could be attributed to any of the following: a malfunctioning of the machine that performs the assembly (by not applying the solvent on the din connector), a dryness channel, the din connector not being assembled to the chamber body, or the din connector assembled with a gap greater than the specification.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.The reported event was confirmed based on the provided photograph.

Event Description

A user facility reported to fresenius via voluntary medwatch#: (b)(4) that a blood leak occurred with a crit-line clip (clic) blood chamber during a patient¿s hemodialysis (hd) treatment.The blood leak was caught immediately by the staff.The machine, a fresenius 2008t hd system, did not alarm.It was reported that the clic blood chamber separated into two parts.The blue sensor disconnected from the part that connects with the dialyzer.The patient was utilizing a fresenius dialyzer and fresenius bloodlines.It was confirmed that the dialyzer and bloodlines had not malfunctioned in any way.There was no defect or damage seen on the clic blood chamber prior to the event.There were no loose connections or issues encountered during prime.The patient¿s estimated blood loss (ebl) was approximately 250 ml.It was confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on the same machine and treatment was completed successfully with new supplies.The sample was available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

H3 plant investigation: the user facility returned complaint samples to the manufacturer for physical evaluation.74 samples were received in their original packaging with product number cl10041021 and lot number 21kr01001.During visual inspection of the returned samples, a separation was noticed in 9 of the samples between the clic port and the din connector.No solvent was found on these samples.The din connector and the clic body port were dimensionally inspected and were found to be acceptable.This kind of failure could be attributed to a malfunctioning of the machine that performs the assembly of the product, by several different causes.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.Based on the sample evaluation that was performed, the alleged failure mode was able to be confirmed.

Event Description

A user facility reported to fresenius via voluntary medwatch # (b)(4) that a blood leak occurred with a crit-line clip (clic) blood chamber during a patient¿s hemodialysis (hd) treatment.The blood leak was caught immediately by the staff.The machine, a fresenius 2008t hd system, did not alarm.It was reported that the clic blood chamber separated into two parts.The blue sensor disconnected from the part that connects with the dialyzer.The patient was utilizing a fresenius dialyzer and fresenius bloodlines.It was confirmed that the dialyzer and bloodlines had not malfunctioned in any way.There was no defect or damage seen on the clic blood chamber prior to the event.There were no loose connections or issues encountered during prime.The patient¿s estimated blood loss (ebl) was approximately 250 ml.It was confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on the same machine and treatment was completed successfully with new supplies.The sample was available to be returned to the manufacturer for physical 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: 15218506
• MDR Text Key: 300310126
• Report Number: 0008030665-2022-00935
• 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,Followup
• Report Date: 10/25/2022

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
• Device Operator: Health Professional
• Device Model Number: CL10041021
• Device Catalogue Number: CL10041021
• Device Lot Number: 21KR01001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 09/01/2022; 10/24/2022
• Supplement Dates FDA Received: 09/19/2022; 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2021
• 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
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 72 YR
• Patient Sex: Male