MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number COMBISET ACCESS FLOW REVERSE CON TWISTER

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/17/2022

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 biomedical technician reported that a blood leak that occurred at the beginning of the patient¿s hemodialysis (hd) treatment.The blood leak was visually observed at the connection when the blood line was twisted in the reverse direction.There was no damage noticed on the connection point, the machine, the dialyzer, or the blood line.The patient¿s estimated blood loss (ebl) was approximately 5 ml.There was no patient injury or medical intervention required as a result of this event.The reverse access was closed, the connection was retightened, and the patient successfully completed treatment on the same machine with the same supplies.The blood line was reported to be available for return to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: d9, h3 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.

Event Description

A user facility biomedical technician reported that a blood leak that occurred at the beginning of the patient¿s hemodialysis (hd) treatment.The blood leak was visually observed at the connection when the blood line was twisted in the reverse direction.There was no damage noticed on the connection point, the machine, the dialyzer, or the blood line.The patient¿s estimated blood loss (ebl) was approximately 5 ml.There was no patient injury or medical intervention required as a result of this event.The reverse access was closed, the connection was retightened, and the patient successfully completed treatment on the same machine with the same supplies.The blood line was reported to be available for return to the manufacturer for evaluation.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• 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: 15347177
• MDR Text Key: 299595706
• Report Number: 0008030665-2022-01001
• Device Sequence Number: 1
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

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: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 22ER01239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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 DIALYZER.; FRESENIUS DIALYZER.
• Patient Sex: Female