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 Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 12/06/2016

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Please note, the needle is a not a fresenius medical care manufactured product.No parts were returned to the manufacturer for physical evaluation.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 results in excessive blood loss, serious injury, and death.Machine alarms may not occur in every blood loss situation.¿.

Event Description

A user facility¿s biomedical engineer reported that during a patient's hemodialysis (hd) treatment using a fresenius 2008t hemodialysis machine and fresenius combiset bloodline, the patient¿s venous needle became dislodged.The machine did not alarm; however, there was no expectation that a machine alarm should have been generated.The patient's estimated blood loss (ebl) was noted as being unknown.Although the patient expired following this event, the nurse manager at the user facility was not able to say with certainty if the patient's death was related to the blood loss or to their co-morbidities.Follow-up information was provided which revealed that the patient was checked 12 minutes before the incident and was found to be fine.Reportedly, the patient had extreme dermatitis, which is believed to have caused the tape to come loose and the needle to dislodge.The blood ran up the back side of the patient's arm, which was the reason provided for why the nurse failed to notice the needle dislodgement.A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine.The 2008t hd machine was found to be alarming and alerting appropriately.Additionally, a diagnostic message occurred.The res calibrated the uf pump to achieve the desired ultrafiltration (uf) rate of 24.0 milliliters (ml).The unit has been returned to service at the user facility without issue.The bloodline is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.

Manufacturer Narrative

Plant investigation: 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 shipped to this account within the selected time frame.A review of the device manufacturing records was performed by the manufacturer on all lots identified.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.Clinical investigation: the reported event was evaluated by a fresenius clinician who concluded the following as it pertains to the fresenius products in use during the patient¿s hd treatment.The blood loss was the direct result of the venous access needle dislodging from the patient.The bloodline is connected to the cannula of the venous needle.The venous needle is not a fresenius manufactured product.There was no allegation that the blood loss was caused by any fresenius products.No documentation exists within the complaint file to conclude that the 2008t hd machine or bloodline caused or contributed to the clinical outcome of blood loss, and the subsequent patient expiration.There is a possible association between the patient¿s severe dermatitis condition which resulted in the needle not being sufficiently secured, and, ultimately, to its dislodgement.

Event Description

A user facility¿s biomedical engineer reported that during a patient's hemodialysis (hd) treatment using a fresenius 2008t hemodialysis machine and fresenius combiset bloodline, the patient¿s venous needle became dislodged.The machine did not alarm; however, there was no expectation that a machine alarm should have been generated.The patient's estimated blood loss (ebl) was noted as being unknown.Although the patient expired following this event, the nurse manager at the user facility was not able to say with certainty if the patient's death was related to the blood loss or to their co-morbidities.Follow-up information was provided which revealed that the patient was checked 12 minutes before the incident and was found to be fine.Reportedly, the patient had extreme dermatitis, which is believed to have caused the tape to come loose and the needle to dislodge.The blood ran up the back side of the patient's arm, which was the reason provided for why the nurse failed to notice the needle dislodgement.A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine.The 2008t hd machine was found to be alarming and alerting appropriately.Additionally, a diagnostic message occurred.The res calibrated the uf pump to achieve the desired ultrafiltration (uf) rate of 24.0 milliliters (ml).The unit has been returned to service at the user facility without issue.The bloodline is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.

• 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: 6223329
• MDR Text Key: 63880766
• Report Number: 8030665-2017-00007
• 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: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• 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
• Date Manufacturer Received: 01/12/2017
• 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: 2008T HEMODIALYSIS MACHINE
• Patient Outcome(s): Death