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

Model Number	03-2742-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/30/2023
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
It was reported that a combi set bloodline separation occurred at the beginning of a patient¿s hemodialysis (hd) treatment which resulted in blood loss.Additional information was provided upon follow-up with a registered nurse (rn) familiar with the event.The rn confirmed that a bloodline separation had occurred approximately fifteen to twenty minutes into a patient's hd treatment.A patient care technician (pct) noticed a puddle of blood on the floor next to the hd machine.The pct saw that the normal saline (ns) line had completely detached at the t-line segment of the arterial line going to the arterial chamber.The pct immediately clamped the arterial and venous lines and stopped the blood pump.The patient's blood was not returned.No abnormalities were noted leading up to the event, and there were no reported pressure changes or any changes to the blood flow rate (bfr).The rn also stated there were no alarms that occurred.Following the leak, a new set of lines was primed with a new dialyzer, and the patient¿s treatment was restarted on the same machine.The patient¿s estimated blood loss (ebl) due to the event was 200 to 300 ml.The rn 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 resetup with new supplies.The sample was not available to be returned for manufacturer evaluation as it was reportedly discarded.However, a photograph of the separation was provided for review.
Event or Problem Description
It was reported that a combi set bloodline separation occurred at the beginning of a patient¿s hemodialysis (hd) treatment which resulted in blood loss.Additional information was provided upon follow-up with a registered nurse (rn) familiar with the event.The rn confirmed that a bloodline separation had occurred approximately fifteen to twenty minutes into a patient's hd treatment.A patient care technician (pct) noticed a puddle of blood on the floor next to the hd machine.The pct saw that the normal saline (ns) line had completely detached at the t-line segment of the arterial line going to the arterial chamber.The pct immediately clamped the arterial and venous lines and stopped the blood pump.The patient's blood was not returned.No abnormalities were noted leading up to the event, and there were no reported pressure changes or any changes to the blood flow rate (bfr).The rn also stated there were no alarms that occurred.Following the leak, a new set of lines was primed with a new dialyzer, and the patient¿s treatment was restarted on the same machine.The patient¿s estimated blood loss (ebl) due to the event was 200 to 300 ml.The rn 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 resetup with new supplies.The sample was not available to be returned for manufacturer evaluation as it was reportedly discarded.However, a photograph of the separation was provided for review.
Additional Manufacturer Narrative
Plant investigation: the complaint sample was not available for manufacturer evaluation.However, a photo of the alleged malfunction was received from the customer.In the photo, a separation could be observed on the arterial line, from the assembly of the saline line to the ¿t¿ saline connector.The condition of the tubing and connector and/or the presence of solvent on the component could not be determined in the photo.This type of failure can be caused by solvent being incorrectly applied to the component, or by a lack of solvent being used during assembly of the components.The involved equipment (medical dispensers) was reviewed, and the applicable maintenance records were found to be conforming/acceptable.No failures were reported during the assembly process.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.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.Based on the provided information, the reported complaint was confirmed.A separation was observed in the photo provided by the customer.

• Brand Name: CUSTOM COMBI SET
• 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: 17192176
• Report Number: 0008030665-2023-00565
• Device Sequence Number: 7413267
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: 11/30/2025
• Device Model Number: 03-2742-9
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 22PR01091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2022
• 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: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 54 KG