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 03-2722-9

Device Problem Fluid/Blood Leak (1250)

Patient Problems Anemia (1706); Blood Loss (2597)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: there is a temporal and causal relationship between hd therapy utilizing the custom combi set and the patient event of blood loss due to a hole in the venous bloodline during treatment requiring a transfusion of red blood cells.This patient has chronic anemia with a low hgb level and in addition was being tested for a gastrointestinal bleed (guaiac stool sample ordered) as a second source of low hemoglobin levels; therefore, any blood loss can negatively affect the patient¿s stability.The reported hole in the venous line caused the patient to lose an approximate 150ml of blood which led to the required intervention.The combi set was not returned for evaluation and the allegation could not be confirmed.The antibiotic administration was a precaution for possible contamination due to the leak.Based on the available information reported by the customer, the hole in the venous line of the custom combi set is the cause of the patient adverse event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A hemodialysis biomedical engineer (biomed) reported that a patient was sent to the emergency room (er) due to blood loss resulting from a hole in the venous line during treatment.The patient was initiated on hemodialysis (hd) therapy, utilizing the fresenius 2008t machine with custom combi set.Shortly after the start of treatment, staff members noticed blood between the chair and the dialysis machine.Blood was also noted to be squirting from the venous line of the dialysis extracorporeal circuit.There was a hole in the venous line confirmed by the clinic staff.The patient¿s blood was returned, and the lines clamped.The estimated blood loss (ebl) of the blood which leaked was 150ml.The physician was present at chairside and evaluated the patient.It was advised that the patient be transported to the emergency room (er) via emergency medical services (ems) as a precaution due to the patient¿s previous hemoglobin (hgb) levels two days prior being 7.4.This patient has chronic anemia for which micera (dose, route, frequency and duration unknown) is prescribed.The patient was treated in the er with antibiotics, 1 dose of gentamycin and vancomycin (dose and route unknown) and 1 unit of packed red blood cells (prbc).The patient also was able to complete hd therapy.The patient¿s hgb was checked and reportedly was good (unspecified value).The patient was released from the er less than eight hours later and returned for their regularly scheduled hd therapy at the clinic two days later.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.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.A product history review 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.

Manufacturer Narrative

Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During disinfection a leak was noted.A visual inspection was performed and a cut in the main line tubing from the bottom of the venous chamber to the injection site was observed.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.A product history review did not reveal a probable cause for the customer complaint.The investigation into the complaint was able to confirm the reported event.

• 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
• MDR Report Key: 9279875
• MDR Text Key: 165247792
• Report Number: 8030665-2019-01700
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 03-2722-9
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 19ER01088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Device Age: MO
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 92