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

Catalog Number UNKNOWN- FMC BLOODLINE

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Lethargy (2560); Blood Loss (2597)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd therapy utilizing the bloodline combi set and the adverse event(s) of lethargy, blood loss and hypovolemia requiring hospitalization and the infusion of prbc¿s.Causality for the event(s) is attributed to the patient¿s venous fistula needle (jms product) becoming dislodged during hd therapy.It is unknown how the needle became dislodged.Access dislodgement is uncommon, however, these event(s) can result in serious injury, significant blood loss and even death, as hd machines may not always detect blood loss.Based on the information available, the bloodline combi set can be disassociated from the event as there is no evidence or indication the bloodline combi set caused or contributed to a serious adverse event.The needle dislodgement occurred at the point where the needle contacts the skin.Additionally, there is no allegation or evidence of a malfunction or of the bloodline combi set failing to perform as expected in relation to the event.Should additional information become available, the need for a clinical investigation will be re-evaluated accordingly.

Event Description

It was reported that a hemodialysis (hd) patient experienced blood loss, hypotension, and lethargy during their treatment.The patient¿s pre-dialysis vital signs were as follows: blood pressure 153/77; pulse 86; respiration 17; temperature 97.8.Approximately 2 hours into their scheduled 4-hour treatment, the patient¿s blood pressure decreased to 97/52 and their pulse decreased to 84.The ultrafiltration was turned off and the patient¿s legs were elevated.The machine subsequently alarmed venous pressure and the blood pump stopped.The patient was lethargic and slow to respond verbally.The venous needle (jms product; manufacturer aware of event) was dislodged but the tape intact on the wings of the needle.Blood was noted to be flowing down the inside of the chair; a puddle of blood was under the chair.The patient¿s estimated blood loss was 525ml.Approximately 400ml normal saline was administered and emergency medical services (ems) was called.Upon discharge from the facility via ems, patient was oriented with a blood pressure of 102/64 and a pulse of 118.The patient was admitted to the hospital.1 unit of packed red blood cells (prbcs) was infused in the emergency room.Additional patient, event, and hospital details were requested, but were not provided.

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 patient 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-conformance's 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.

• Brand Name: FMC BLOODLINE
• 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: 8270714
• MDR Text Key: 133872677
• Report Number: 8030665-2019-00168
• Device Sequence Number: 1
• Product Code: FJK
• 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,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- FMC BLOODLINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 100 DEXTROSE; 3M MICROPORE TAPE; FRESENIUS 2008K2 MACHINE; FRESENIUS DIALYZER; FRESENIUS GRANUFLO 2.0K, 2.5CA, 1.0MG; FRESENIUS NATURALYTE 4000; FRESENIUS NORMAL SALINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 81