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

Catalog Number 03-2722-9

Device Problem Detachment Of Device Component (1104)

Patient Problem Blood Loss (2597)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No parts were returned to the manufacturer for physical evaluation.The post market surveillance department received medical records associated with the reported event.Both a clinical investigation and plant investigation are in process.A supplemental mdr will be submitted upon completion of these activities.

Event Description

A spontaneous, serious blood loss event, which occurred during a hemodialysis (hd) treatment, was reported to fmcna, llc by a nurse from the user facility on (b)(6) 2016.The report concerns a (b)(6) patient with end stage renal disease (esrd) on chronic hemodialysis.On (b)(6) 2016, at 4:00 pm, while the patient underwent a routinely scheduled dialysis treatment, the needle line disconnected from the bloodline.The separation occurred approximately 2 hours and 15 minutes into the treatment and resulted in an episode of blood loss.The patient's estimated blood loss (ebl) was noted as being approximately 500ml.The patient was found to be unresponsive, but with a carotid pulse.Supplemental oxygen was administered.The blood pump was stopped, and the bleeding was addressed; a normal saline bolus was started.The patient initially reported no symptoms upon regaining consciousness, but soon developed nausea and experienced chest pressure.The patient vomited, and then their blood pressure was found to have dropped to its lowest monitored value of 58/43.A total of 2.6 liters of normal saline (ns) was administered.The patient reported feeling better; both the chest pressure and nausea experienced by the patient had subsided.The medical doctor (md) responded and assisted at chairside; emergency medical services (ems) were contacted through chairside (as per md orders) and 1000cc of normal saline (ns) was administered.A peripheral intravenous (iv) line was placed by ems upon their arrival.Following placement of the peripheral iv line, the patient's arteriovenous (av) graft lines were removed, and an additional 1000cc of ns was administered.The patient's blood pressure was noted as being 126/35 at the time of transfer from unit by ems.Patient alert and oriented times 3.The patient was transferred to, and then admitted to the hospital, where 1 unit of packed red blood cells was transfused.The patient was subsequently discharged from the hospital on the same day.The patient has since recovered from this event, and was scheduled to return to receiving routine hd treatments at their home facility beginning (b)(6) 2016.Following the event, the 2008t hemodialysis (hd) machine was pulled from service for evaluation.The onsite biomedical technician performed functional testing and verified the unit was in good operating condition.Unit passed all testing; no repairs or calibrations required.Additionally, no bloodline device issues were visible; specifically, no holes, separations, or tubing deficiencies observed.The fresenius bloodline is not available for evaluation as it was discarded by the user facility.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, 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 from the reported catalog number (03-2722-9) shipped to this account within the selected time frame.A records review was performed on the fifteen (15) lots identified.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.The lots passed all release criteria.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 reported adverse event was not able to be confirmed as it relates to the fresenius bloodline.

Manufacturer Narrative

Clinical investigation: the patient medical records were provided by the facility on june 1, 2016.A clinical investigation was performed to determine any possible causal relationship between the hemodialysis treatment and the adverse event.A (b)(6), female end stage renal disease (esrd) patient presented to an in-center clinic on (b)(6) 2016 for a routine hemodialysis session.At approximately 4:00 pm, the patient¿s blood pressure (bp) was recorded at 58/43 and the hd venous needle was found to be disconnected from the bloodline set.The line was clamped, and then the hd treatment was terminated.The patient endured a temporary loss of consciousness.The patient received a saline bolus, and regained consciousness (total saline administered was 2.6 liters).Shortly thereafter, the patient complained of chest pressure and nausea, which resolved after the patient¿s bp was restored to normal readings (123/46).The patient was transported to the hospital and admitted to the emergency room (er) where she received one unit of packed red blood cells (prbc).Patient was discharged the same day.Additionally, the patient resumed regularly scheduled hd treatments on (b)(6) 2016.The medical record revealed that the blood loss was a direct result of the patient¿s hd venous needle becoming disconnected from the venous bloodline set.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.There is no documentation in the medical record to conclude that there was a causal relationship between the 2008t hemodialysis (hd) machine or the fresenius bloodline and the patient¿s blood loss, low bp, or transient unresponsiveness leading to hospitalization.In addition, the 2008t hemodialysis machine operator¿s manual (p/n 490122 rev.N) contains the following warning on pg.103 related to the occurrence of low venous pressure alarms.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.

• Brand Name: CUSTOM COMBI SET
• 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: 5697853
• MDR Text Key: 46512443
• Report Number: 8030665-2016-00264
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• 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
• Date Manufacturer Received: 06/10/2016
• 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: 66 YR
• Patient Weight: 68