MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET TRUE FLOW; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Blurred Vision (2137); Loss of consciousness (2418); Blood Loss (2597)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note, the needle is not a fresenius medical care manufactured product.However, an event notification was forwarded to the device manufacturer.No parts were returned to the manufacturer for physical evaluation.Plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: the patient medical records were provided by the facility on may 4, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.Based on the provided medical records, on (b)(6) 2016, this (b)(6), male, end stage renal disease (esrd) patient was undergoing a routine hemodialysis (hd) treatment.Approximately 2 hours into the treatment, the venous needle was found to be dislodged from the patient access.Reportedly, the unit alarmed for low blood pressure (bp) prior to the discovery of the dislodgement.The bp was 74/56 at that time.The patient¿s estimated blood loss (ebl) was approximately 1000ml.The patient complained of blurred/dark vision, and then became unresponsive for a period of time.After receiving a bolus of normal saline (ns) with approximately 1300ml being infused, the patient regained consciousness.The patient¿s bp was 81/52 and hgb count was 8.4 immediately after the incident.The patient was transported to the hospital via emergency medical services (ems) in stable condition.The patient was admitted to the hospital and received a transfusion of two units of blood.The patient was discharged the following day ((b)(6) 2016), and has since resumed regular hd treatments.The provided patient medical records contained the following documentation.Treatment record for the day the event occurred.Treatment sheets were also provided for (b)(6) sessions and an unrelated prior hospitalization.The medical records did not contain an ems transport record, or any hospital records (emergency room and/or in-patient) related to the event.The 2008t hemodialysis operator¿s manual p/n 490122 rev n contains the following user warning.¿the low venous pressure alarm may not occur with every disconnection or needle dislodgement.Check all bloodlines for leaks after the treatment has started.Keep access sites uncovered and 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.¿ based on the provided documentation and details noted by the user facility, the patient blood loss occurred as a result of the venous access needle becoming dislodged.The bloodline is connected to the cannula of the venous needle.The venous needle with cannula is not manufactured by fresenius medical care.There was no allegation that the blood loss was caused by a loose or faulty connection.Medical records do not indicate there was a causal relationship between the 2008t hemodialysis (hd) machine, the fresenius bloodline, and the patient's complaint of blurred/dark vision, or the acute hemorrhage resulting in anemia.There is no documentation in the medical record to conclude that the 2008t hd machine or fresenius bloodline caused or contributed to the clinical outcome of blood loss and hospitalization.

Event Description

A nurse at the user facility reported a blood loss event which resulted in adverse symptoms and subsequent hospitalization while an end stage renal disease (esrd) patient was undergoing a routine hemodialysis treatment by way of an arterial-venous fistula access site.At 12:14 pm, the hemodialysis (hd) treatment was initiated without issue.The patient's blood pressure (bp0 and pulse were stable until approximately 2:19 pm.At that time, the patient complained of blurred/dark vision.As the patient started to become unresponsive, the staff noticed the venous needle had dislodged from access and was actively bleeding.A large amount of blood was observed on the floor under and behind the chair.The patient received a bolus of normal saline (ns) and an infusion was started; bp 74/56, pulse 88.The machine alarmed for low blood pressure prior to the observed dislodgement.At 14:22, after receiving 500ml of ns, the patient started talking to staff; patient alert to person, place and time.Emergency medical services (ems) was contacted and arrived at 2:30 pm.Hemostasis achieved.The patient's estimated blood loss (ebl) was reported as being approximately 1 liter.Approximately 1300ml of normal saline was administered.Patient care was transferred to ems at 2:30 pm.The patient was admitted to the hospital and received a transfusion of two units of blood.The patient was discharged the following day ((b)(6) 2016), and has since resumed regular hd treatments.The 2008t hemodialysis machine was pulled from service following this event for analysis.Functional testing performed by the biomedical engineer confirmed the unit was operating properly.The unit has been returned to service at the user facility without issue.

Manufacturer Narrative

The device was not returned nor was a companion sample available to the manufacturer for physical evaluation.No malfunction was confirmed during evaluation of the alternate samples.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 bloodline tubing sets shipped to this account within the selected time frame.A records review was performed on each identified lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.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.Therefore, the complaint was not able to be confirmed.

• Brand Name: COMBISET TRUE FLOW
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5679714
• MDR Text Key: 45962195
• Report Number: 8030665-2016-00245
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

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
• Device Catalogue Number: 03-2722-9
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 85