MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. HOME HEMO COMBI SET FOR CANADA; HEMODIALYSIS SYSTEM FOR HOME USE

Catalog Number 03-2932-6

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/23/2021

Event Type  malfunction  

Event Description

It was reported that a combi set blood leak occurred during the blood return procedure at the end of a patient's hemodialysis (hd) treatment.The clamp on the saline line failed to stay closed and blood reportedly sprayed out.It was reported that the saline line disconnected.There were no alarms from the hd machine.Minimal blood loss was reported; an exact volume was unknown.No re-setup was needed and the blood return procedure was reportedly completed with the same set of bloodlines.There were no known adverse effects or injuries, and no medical intervention was required.Following the event, the patient stated they would start using bloodlines from a different lot number.A photo showing the front of an hd machine with bloodlines connected was provided for review.In the photo there are visible splatters of blood underneath the combi set tubing.The actual complaint device was discarded; however, a companion sample was reportedly available to be returned for evaluation.

Manufacturer Narrative

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

Event Description

It was reported that a combi set blood leak occurred during the blood return procedure at the end of a patient's hemodialysis (hd) treatment.The clamp on the saline line failed to stay closed and blood reportedly sprayed out.It was reported that the saline line disconnected.There were no alarms from the hd machine.Minimal blood loss was reported; an exact volume was unknown.No re-setup was needed and the blood return procedure was reportedly completed with the same set of bloodlines.There were no known adverse effects or injuries, and no medical intervention was required.Following the event, the patient stated they would start using bloodlines from a different lot number.A photo showing the front of an hd machine with bloodlines connected was provided for review.In the photo there are visible splatters of blood underneath the combi set tubing.The actual complaint device was discarded; however, a companion sample was reportedly available to be returned for evaluation.

Manufacturer Narrative

Additional information: a1, a2, a3, a4 the plant investigation is still in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a combi set blood leak occurred during the blood return procedure at the end of a patient's hemodialysis (hd) treatment.The clamp on the saline line failed to stay closed and blood reportedly sprayed out.It was reported that the saline line disconnected.There were no alarms from the hd machine.Minimal blood loss was reported; an exact volume was unknown.No re-setup was needed and the blood return procedure was reportedly completed with the same set of bloodlines.There were no known adverse effects or injuries, and no medical intervention was required.Following the event, the patient stated they would start using bloodlines from a different lot number.A photo showing the front of an hd machine with bloodlines connected was provided for review.In the photo there are visible splatters of blood underneath the combi set tubing.The actual complaint device was discarded; however, a companion sample was reportedly available to be returned for evaluation.

Manufacturer Narrative

Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received and a physical evaluation could not be performed.However, a photograph of the combi set connected to the machine was provided by the customer.Evidence of a blood leak was apparent in the provided photograph.The photograph shows blood leaking from the saline line with the closed clamp.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.The reported event was confirmed based on the provided photograph.Despite this, a cause for the reported failure could not be established.

• Brand Name: HOME HEMO COMBI SET FOR CANADA
• Type of Device: HEMODIALYSIS SYSTEM FOR HOME USE
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13234187
• MDR Text Key: 285347582
• Report Number: 8030665-2022-00042
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 03-2932-6
• Device Lot Number: 20LR01003
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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 2008K@HOME MACHINE; FRESENIUS 2008K@HOME MACHINE; FRESENIUS 2008K@HOME MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 59 KG