MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008

Catalog Number 03-2722-9

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Loss of consciousness (2418); Diaphoresis (2452); Blood Loss (2597)

Event Date 08/08/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore, the failure mode cannot be confirmed.However, a records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.A labeling evaluation was performed.No indication of labeling being a contributing factor in the occurrence of this incident was identified.

Event Description

A user facility reported via user facility medwatch a hemodialysis patient experienced a blood leak.Reportedly, 3 hours into the scheduled 3.5 hour treatment, blood was noted under the patient's chair.The patient's estimated blood loss was 600cc.The patient was immediately assessed and found to be unresponsive, diaphoretic, and had agonal breathing.The patient became responsive after being given 2000cc of normal saline.The patient was then transported via ambulance to the hospital and remained hospitalized until their discharge on (b)(6) 2015.Follow-up information was received, which revealed that the patient has fully recovered from this incident.Upon examination of the device, the user found that the venous line had disconnected from the venous needle connection.Additionally, the user noted that approximately 300cc of blood remained in the dialyzer and lines which could not be returned to the patient.The actual sample is not available for evaluation.(b)(4).

Manufacturer Narrative

The patient medical records were provided by the facility on 09/17/2015.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.There is no documentation in the medical record that indicates a causal relationship between the custom combiset and the patient's hospitalization for anemia.Medical records reveal that the patient's bleeding and anemia was a result of chronic kidney disease and the patient's blood loss secondary to the patient inadvertently dislodging her venous access.

Event Description

Additional information: the patient was transferred to the hospital after inadvertently dislodging her dialysis needle.According to the patient's daughter, the patient tried to pull her cover up, but ended up pulling out her access and began bleeding profusely.Upon arrival, the patient was found to be hypotensive, but asymptomatic and profoundly anemic.The physician documented that the patient's anemia appeared to be both acute and chronic, secondary to multiple factors including recent blood loss from her av graft as well as her chronic renal disease.The patient was transfused one unit packed red blood cells, continued on intravenous normal saline, and started epogen.The patient was seen by infectious disease on (b)(6) 2015 which revealed that the patient's leukocytosis was likely a systemic inflammatory response to the acute blood loss.

• Brand Name: FRESENIUS COMBISET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331 ; parque industrial reynosa
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 0245 ; 8006621237
• MDR Report Key: 5088436
• MDR Text Key: 26470071
• Report Number: 8030665-2015-00427
• 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
• Type of Report: Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15HR01250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 60