MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET SMARTECH BLOODLINE; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number 03-2722-9C

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility hemodialysis (hd) technician reported blood leaking from a fresenius combiset during a patient¿s treatment.The leak was coming from the ¿top of the arterial side, through the round edges¿ of the integrated clic blood chamber.It was reported that a tiny spot of dried blood was noticed on the exterior of the tubing set approximately two hours into the patient¿s hd treatment.There was no visible damage noted on the device.The dried blood was found just below the connection point on the tubing set.It was suspected that the clic blood chamber was not sealed properly.Blood was not actively leaking when this was noticed.The estimated blood less was said to be less than 1 ml.There were no machine alarms during the treatment, and no other issues.The patient was able to continue and complete their treatment with the same supplies.The patient was dialyzing on a fresenius 2008t machine and utilizing a fresenius optiflux dialyzer.The combiset was not available for evaluation as it was reportedly discarded.Photos were taken of the sample and provided for review.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, a photograph of the device was provided by the user facility.In the photograph, a confirmed leak was visible in the lens seal of the clic blood chamber.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 hemodialysis (hd) technician reported blood leaking from a fresenius combiset during a patient¿s treatment.The leak was coming from the ¿top of the arterial side, through the round edges¿ of the integrated clic blood chamber.It was reported that a tiny spot of dried blood was noticed on the exterior of the tubing set approximately two hours into the patient¿s hd treatment.There was no visible damage noted on the device.The dried blood was found just below the connection point on the tubing set.It was suspected that the clic blood chamber was not sealed properly.Blood was not actively leaking when this was noticed.The estimated blood less was said to be less than 1 ml.There were no machine alarms during the treatment, and no other issues.The patient was able to continue and complete their treatment with the same supplies.The patient was dialyzing on a fresenius 2008t machine and utilizing a fresenius optiflux dialyzer.The combiset was not available for evaluation as it was reportedly discarded.Photos were taken of the sample and provided for review.

• Brand Name: COMBISET SMARTECH BLOODLINE
• 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
• MDR Report Key: 12206229
• MDR Text Key: 262872451
• Report Number: 8030665-2021-01187
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861102266
• UDI-Public: 00840861102266
• Combination Product (y/n): N
• PMA/PMN Number: K201207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 03-2722-9C
• Device Catalogue Number: 03-2722-9C
• Device Lot Number: 21CR01244
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 59 YR
• Patient Weight: 60