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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Dizziness (2194)

Event Date 07/22/2022

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported to fresenius that a blood leak occurred when the connection between the fresenius bloodlines and needle luer lock separated approximately 30 minutes into the patient¿s hemodialysis (hd) treatment.It was later reported that the patient was sent to the emergency room (er) where they were evaluated.The patient¿s hemoglobin (hgb) was reportedly 8.3 and no transfusion was required.The patient was released from the er and was treated at the clinic on the following day.No further information was initially provided.Additional details were provided by the clinic manager.The patient was at the clinic for a regularly scheduled 3 hour and 15-minute hd treatment utilizing an arteriovenous fistula (avf).Approximately 30 minutes into the treatment, a blood leak was noted at the connection between the bloodlines and needle luer lock.This was confirmed to be secure prior to the start of treatment.No blood leak alarm was triggered.An air detected message was received after the leak was noted.The patient lost >600ml of blood and reported feeling dizzy.The patient was transported to the er.The patient was evaluated and had labs drawn.The patient¿s hgb was 8.3 and no medical intervention was required.Labs are considered a diagnostic tool and not medical intervention.The patient went to the clinic the following day to complete the treatment.The patient is continuing to complete regularly scheduled hd treatments.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

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 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.

Event Description

It was reported to fresenius that a blood leak occurred when the connection between the fresenius bloodlines and needle luer lock separated approximately 30 minutes into the patient¿s hemodialysis (hd) treatment.It was later reported that the patient was sent to the emergency room (er) where they were evaluated.The patient¿s hemoglobin (hgb) was reportedly 8.3 and no transfusion was required.The patient was released from the er and was treated at the clinic on the following day.No further information was initially provided.Additional details were provided by the clinic manager.The patient was at the clinic for a regularly scheduled 3 hour and 15-minute hd treatment utilizing an arteriovenous fistula (avf).Approximately 30 minutes into the treatment, a blood leak was noted at the connection between the bloodlines and needle luer lock.This was confirmed to be secure prior to the start of treatment.No blood leak alarm was triggered.An air detected message was received after the leak was noted.The patient lost >600ml of blood and reported feeling dizzy.The patient was transported to the er.The patient was evaluated and had labs drawn.The patient¿s hgb was 8.3 and no medical intervention was required.Labs are considered a diagnostic tool and not medical intervention.The patient went to the clinic the following day to complete the treatment.The patient is continuing to complete regularly scheduled hd treatments.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

• Brand Name: CUSTOM COMBI SET
• Type of Device: 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; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15199610
• MDR Text Key: 297893447
• Report Number: 0008030665-2022-00927
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03-2742-9
• Device Catalogue Number: 03-2742-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 70 KG