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 09/16/2021

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 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 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.

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
• 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: 12572901
• MDR Text Key: 274715190
• Report Number: 8030665-2021-01541
• 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: 10/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/06/2021
• 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: 76 YR
• Patient Weight: 78