MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET SMARTECH BLOODLINE (NO HEPARIN); ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 03-2742-9C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 09/22/2023

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 registered nurse (rn) reported that the tubing on a combiset smartech bloodline fell apart at the saline ¿t¿ connection towards the end of a patient¿s hemodialysis (hd) treatment.As a result, the patient¿s blood was unable to be completely returned.Additional information was provided upon follow-up with the facility¿s clinical manager (cm).The cm confirmed the tubing separated at the saline ¿t¿ connection while the patient¿s blood was being returned.A photo showing the separation was provided for review.Once identified, the lines were clamped and no additional blood was returned.Only the lower aspect of the arterial lines was able to be returned, which was about 50 ml.Blood from the venous line could not be returned.The patient¿s estimated blood loss was approximately 250-300 ml.There were no audible alarms at the time of the separation.The separation was readily visible and leaking saline.The patient¿s blood pressure (bp) was a little bit lower than desired at the time of reinfusion, and thus they were given 300 ml of extra normal saline (ns) to support the low bp.However, it was confirmed the patient did not experience any symptoms.The cm stated the ns given is considered normal intervention in a case like this, and it is under the discretion of the rn in charge.Per the cm, the patient was an acute renal failure patient, and it is preferred to keep a systolic bp above 100 to ensure the kidneys remain perfused and are not left in a dehydrated state.It was confirmed the patient¿s hemoglobin remained stable, and no medical intervention was required.The sample was not available to be returned for manufacturer evaluation as it had been discarded.

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.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.A device history record (dhr) review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.In addition, there was no associated rework related to this failure during the assembly of the lot.The lot met all specifications for release.It was found that during the assembly process of this lot there was personnel in their training period.Based on the provided information, the reported complaint was confirmed.A separation was observed in the photo provided by the customer.

Event Description

A user facility registered nurse (rn) reported that the tubing on a combiset smartech bloodline fell apart at the saline ¿t¿ connection towards the end of a patient¿s hemodialysis (hd) treatment.As a result, the patient¿s blood was unable to be completely returned.Additional information was provided upon follow-up with the facility¿s clinical manager (cm).The cm confirmed the tubing separated at the saline ¿t¿ connection while the patient¿s blood was being returned.A photo showing the separation was provided for review.Once identified, the lines were clamped and no additional blood was returned.Only the lower aspect of the arterial lines was able to be returned, which was about 50 ml.Blood from the venous line could not be returned.The patient¿s estimated blood loss was approximately 250-300 ml.There were no audible alarms at the time of the separation.The separation was readily visible and leaking saline.The patient¿s blood pressure (bp) was a little bit lower than desired at the time of reinfusion, and thus they were given 300 ml of extra normal saline (ns) to support the low bp.However, it was confirmed the patient did not experience any symptoms.The cm stated the ns given is considered normal intervention in a case like this, and it is under the discretion of the rn in charge.Per the cm, the patient was an acute renal failure patient, and it is preferred to keep a systolic bp above 100 to ensure the kidneys remain perfused and are not left in a dehydrated state.It was confirmed the patient¿s hemoglobin remained stable, and no medical intervention was required.The sample was not available to be returned for manufacturer evaluation as it had been discarded.

• Brand Name: COMBISET SMARTECH BLOODLINE (NO HEPARIN)
• 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; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18121305
• MDR Text Key: 329248136
• Report Number: 0008030665-2023-01032
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201207
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9C
• Device Lot Number: 22LR01246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male