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

Model Number	03-2722-9C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility charge nurse (cn) reported a combiset blood leak that occurred within the first few minutes of a patient¿s hemodialysis (hd) treatment.Blood was observed leaking externally from the venous end of the device, directly above the ¿clear hub¿ where the needle connects to the tubing.The cn stated that it looked like the tubing was not fully sealed (or bonded) to the connector.The patient was dialyzing on a fresenius 2008t hd machine and utilizing an optiflux dialyzer.There were no machine alarms.No leaking was noticed during the priming phase.As soon as the leak was identified, the treatment was paused.The lines were reversed and the patient¿s blood was returned manually.The patient¿s estimated blood loss (ebl) was reportedly less than 10 ml.The cn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on the same machine.The sample was not available to be returned for evaluation as it was reportedly discarded.Photos of the defect were also unavailable.
Event or Problem Description
A user facility charge nurse (cn) reported a combiset blood leak that occurred within the first few minutes of a patient¿s hemodialysis (hd) treatment.Blood was observed leaking externally from the venous end of the device, directly above the ¿clear hub¿ where the needle connects to the tubing.The cn stated that it looked like the tubing was not fully sealed (or bonded) to the connector.The patient was dialyzing on a fresenius 2008t hd machine and utilizing an optiflux dialyzer.There were no machine alarms.No leaking was noticed during the priming phase.As soon as the leak was identified, the treatment was paused.The lines were reversed and the patient¿s blood was returned manually.The patient¿s estimated blood loss (ebl) was reportedly less than 10 ml.The cn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on the same machine.The sample was not available to be returned for evaluation as it was reportedly discarded.Photos of the defect were also unavailable.
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.

• Brand Name: COMBISET SMARTECH BLOODLINE
• 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
• MDR Report Key: 12572901
• Report Number: 8030665-2021-01541
• Device Sequence Number: 10993967
• Product Code: KOC
• UDI-Device Identifier: 00840861102266
• UDI-Public: 00840861102266
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K201207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2021

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: 07/31/2022
• Device Model Number: 03-2722-9C
• Device Catalogue Number: 03-2722-9C
• Device Lot Number: 21JR01232
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 76 YR
• Patient Weight: 78