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

Catalog Number 03-2742-9

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Loss of consciousness (2418); Blood Loss (2597)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note, the needle is a 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.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.¿ manufacturing 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 from the reported catalog number (03-2742-9) 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 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.Clinical investigation: the patient medical records were provided by the facility on august 15, 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, an (b)(6) female patient presented to the hemodialysis clinic for treatment.The patient¿s hd treatment was initiated at 10:46 am.At 11:53 am, the patient was found to be unconscious.The access needle was found to be dislodged, and approximately 250cc of blood was on the floor beside the patient.911 services were contacted and the bleeding was stopped.The patient was administered a 600cc bolus of normal saline.The patient was transported to the emergency room by ems upon their arrival.The patient¿s unresponsive episode is not addressed in the medical record nor is there any indication of a cause for the unresponsive episode.Medical records and the statement of the user facility nurse suggest this event was accidental on the part of the patient and not any defect of the patient¿s hemodialysis products.At this time, no conclusion can be made regarding any causality between the patient¿s removal of the hemodialysis needle resulting in blood loss and the patient¿s hemodialysis products.There is no documentation in the medical record that indicates a causal relationship between the 2008t hemodialysis (hd) machine, the fresenius custom combi set, and the patient¿s blood loss and hospitalization.

Event Description

A nurse at a user facility reported that a patient was found unresponsive during hemodialysis treatment at 11:53 am.The patient started hemodialysis treatment at 10:46 am.At 11:53 am, the patient was found unconscious and the needle was dislodged from the patient's arm.The patient lost approximately 250cc of blood, which was on the floor beside the patient.The machine did not alarm.The staff called 911 emergency services and stopped the bleeding.The patient received a 600cc bolus of normal saline (ns).At 11:59 am, emergency medical services (ems) arrived.At the time of their arrival, the patient's blood pressure was 160/86 and heart rate was 118.At 12:02 pm, the patient was alert and talking with staff.The patient was transported to the emergency room (er) at 12:14 pm.The patient presented to the hospital with a bandage to her right arm fistula with no current bleeding.The patient remained stable and was in no distress and no further bleeding occurred.The patient did not require a blood transfusion.The patient was discharged to the nursing home facility the same day in stable condition.Follow-up information with the nurse at the user facility revealed that the patient has an old cva and partially paralyzed on the left side.The patient will move the right side/right arm often.The nurse suspected that the patient accidentally knocked the needle out, even though it is taped down onto the arm.The 2008t hemodialysis machine was pulled from service following this event in order to perform an evaluation.The user facility's on-site biomedical engineer confirmed that the unit was operating properly.The unit has been returned to service at the user facility without issue.The bloodline product is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.

• 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; parkque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5917407
• MDR Text Key: 53593990
• Report Number: 8030665-2016-00452
• 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
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9
• Other Device ID Number: 00840861100309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2016
• 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: PRILOSEC
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 52