MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET SMARTECH BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	03-2722-9C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/08/2023
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 reported that a crit-line blood chamber leaked blood at the beginning of a patient¿s hemodialysis (hd) treatment.It was noted that blood flow was increased to 200 to 400 and a trace of blood was in the dialyzer header.Once the blood was noticed, treatment was stopped and the blood chamber was switched out.Upon follow up, it was confirmed that there were no machine alarms as it does not alarm for minor leaks.The patient was dialyzing on a fresenius 2008t machine and utilizing a fresenius high flux dialyzer.The patient¿s estimated blood loss was approximately 1ml.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.It was confirmed the patient was able to complete their treatment on a new machine with new supplies.The sample was reported to not be available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Correction provided in d1, d2, d4, d10 and g4.
Event or Problem Description
A user facility reported that a crit-line blood chamber leaked blood at the beginning of a patient¿s hemodialysis (hd) treatment.It was noted that blood flow was increased to 200 to 400 and a trace of blood was in the dialyzer header.Once the blood was noticed, treatment was stopped and the blood chamber was switched out.Upon follow up, it was confirmed that there were no machine alarms as it does not alarm for minor leaks.The patient was dialyzing on a fresenius 2008t machine and utilizing a fresenius high flux dialyzer.The patient¿s estimated blood loss was approximately 1ml.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.It was confirmed the patient was able to complete their treatment on a new machine with new supplies.The sample was reported to not be available to be returned for manufacturer evaluation.
Event or Problem Description
A user facility reported that a crit-line blood chamber leaked blood at the beginning of a patient¿s hemodialysis (hd) treatment.It was noted that blood flow was increased to 200 to 400 and a trace of blood was in the dialyzer header.Once the blood was noticed, treatment was stopped and the blood chamber was switched out.Upon follow up, it was confirmed that there were no machine alarms as it does not alarm for minor leaks.The patient was dialyzing on a fresenius 2008t machine and utilizing a fresenius high flux dialyzer.The patient¿s estimated blood loss was approximately 1ml.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.It was confirmed the patient was able to complete their treatment on a new machine with new supplies.The sample was reported to not be available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the customer for the three (3) month time frame which immediately preceded the event¿s occurrence date.This review included the lot numbers for all fresenius combiset bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• 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; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17776373
• Report Number: 0008030665-2023-00873
• Device Sequence Number: 3470608
• Product Code: FJK
• UDI-Device Identifier: 00840861100552
• UDI-Public: 00840861100552
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2023
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2024
• Device Catalogue Number: 03-2722-9C
• Device Lot Number: 21HR01290
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 11/23/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/16/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLIC BLOOD CHAMBER; CLIC BLOOD CHAMBER; FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Sex: Unknown