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

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: the 2008t hemodialysis machine, operators manual p/n 490122 rev n, page 285 documents the following user warning: ¿check all bloodlines for leaks after the treatment has started.Keep access sites uncovered ad monitored.Improper bloodline connections or needle dislodgements can result in excessive blood loss, serious injury, and death.Machine alarms may not occur in every blood loss situation.¿ the blood loss was a direct result of the patient¿s dialysis venous access needle becoming dislodged from the insertion site.The bloodline is connected to the cannula of the venous needle.The venous needle with cannula is not manufactured by fresenius medical care.There is no allegation that the blood loss was caused by a loose or faulty connection.Additionally there is no documentation to conclude that the bloodline caused or contributed to the clinical outcome of blood loss requiring a transfusion of two units of blood (prbc) and subsequent hospital observation.It was reported that the patient¿s access site was covered, which is contraindicated.

Event Description

A biomedical technician at a user facility reported that a patient lost approximately two or three units of blood during their hemodialysis (hd) treatment after the venous needle dislodged from the patient¿s access.The 2008t hd machine did not generate an alarm as it is not intended to do so.Follow-up revealed that the patient moves during treatment and has to be reminded to keep the access site in the arm straight.Approximately two hours into a four hour treatment, the nurse noticed the patient was losing blood.The estimated blood loss (ebl) was noted as being approximately 750 milliliters (ml) by the nurse overseeing the hd treatment.The nurse occluded the needle access site with one hand and stopped the machine with the other.The nurse did not allege a malfunction or defect of the needle and/or fresenius bloodline.The nurse assumed that the patient had been moving which resulted in the venous needle dislodgement.Following the blood loss event and the termination of the hd therapy, after an undisclosed period of time, the patient became ill, and vomited a small amount of bile.However, the patient never lost consciousness.Fluid boluses (amount unknown) were given and the patient was transferred to the intensive care unit (icu) for observation and a transfusion of two units of packed red blood cells (prbc).After the blood transfusion, the patient's condition was noted as being stable.The patient has not missed any hd treatments and has continued regularly scheduled hd therapy sessions without any further incidents.Following the event, the 2008t hd machine was removed from service for evaluation by the on-site biomedical technician.Functional testing performed by the biomed confirmed the system was operating properly.The unit was returned to service at the user facility without a recurrence of the event as reported.No malfunction of the fresenius bloodlines in use during the hd treatment was alleged, observed, or identified prior to, during, or following the event.The bloodline device was not available to be returned to the manufacturer as it was discarded by the user facility.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodlines shipped to this account within the selected time frame.A records review was performed on all lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances or abnormalities identified during the manufacturing process of these lots which could be associated with the reported event.The product lots involved in the records review met all specifications for release.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event and all lots met release criteria.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6589259
• MDR Text Key: 75891641
• Report Number: 8030665-2017-00267
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: JMS SYSLOC NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 102