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

Catalog Number 03-2742-9

Device Problem Fluid/Blood Leak (1250)

Patient Problems Dyspnea (1816); Nausea (1970)

Event Date 09/24/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation conclusion: a temporal relationship with the adverse events of the patient¿s blood loss, dyspnea and nausea and the fresenius blood lines and hemaclip exist.However, there is no documentation of any defects at the connection site of the venous blood line to the catheter or any other venous blood line issues.The initial report from the clinic did state that the bloodlines were reversed during treatment and that they were found to be loose when the blood leak was discovered; however, follow up information documented that it was unknown if there was any loose connection.It is unknown what may have occurred to cause the leak at the connection with ten minutes remaining in the treatment.There is no documentation to state if the patient access site was uncovered.Reportedly, the hemaclip was intact on the venous line, but it is unknown what make of catheter was utilized and if it was compatible with the hemaclip.The adverse event was a direct result of the patient¿s dialysis venous line leaking at the connection leading to the blood loss, nausea and dyspnea with subsequent hospitalization.

Event Description

On (b)(6) 2018 a hemodialysis (hd) clinic reported that a patient with end stage renal disease (esrd) complained of shortness of breath and nausea during treatment.The bloodlines had been reversed earlier in the treatment and staff noted the venous bloodline was loose from the central venous catheter (cvc) (not a fresenius product) arterial limb with hemoclip intact.The estimated blood loss of the patient was 400-500ml.The patient was administered oxygen and emergency medical services (ems) was called and transferred the patient to the hospital where they were admitted.Additional information was obtained through follow up with the clinic manager on (b)(6) 2018.This female patient on thrice weekly hd therapy initiated her dialysis treatment on (b)(6) 2018 utilizing the optiflux 160nre dialyzer on the fresenius 2008t machine.The treatment was scheduled for four hours.With approximately 10 minutes remaining in treatment a blood leak was observed at the connection between the venous bloodline and the cvc arterial limb connection.The patient then complained of nausea and dyspnea.Per the clinic manager, it was not noted if there were any loose connections; however, there was no visible damage or defect seen on the bloodlines.Treatment was stopped and the patient was placed on oxygen.The patient was transported to the hospital via ems and admitted.The estimated blood loss was 500ml.Hospital course is unknown and discharge date is not known.The patient has since returned to their regularly scheduled hd therapy.

Manufacturer Narrative

The plant received companion samples with the original packaging.During the evaluation of the actual sample the alleged failure stated in the complaint was not confirmed.A visual inspection was performed to the venous and the arterial patient end connector, which were closely inspected and found to be acceptable.In addition, the rest of the bloodline arterial and venous line was inspected and found to be acceptable.The male conical fitting of the venous and arterial patient connector was dimensionally inspected using ansi male gauge iso 594/1 1986.The samples were found within the acceptable range.In addition, the instructions for use (ifu p/n 71-4210) that is included in the packaging of the product contain indications, and warnings to perform the connection.The device history record [dhr] of this product was reviewed and no nonconformance reports or other abnormalities during the assembly of this lot were found.The product involved met specifications.

Manufacturer Narrative

Added fresenius 2008t machine, fresenius dialyzer, and fresenius patient connector clip.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

• 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: 7980055
• MDR Text Key: 124204295
• Report Number: 8030665-2018-01622
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 18HR01198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Device Age: MO
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 53