MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FMC BLOODLINES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Exsanguination (1841)

Event Date 08/14/2015

Event Type  Injury  

Manufacturer Narrative

The post market surveillance department has reviewed medical records and treatment sheet.The clinical investigation reveals the following: medical records do not indicate there was a causal relationship between the bloodline and the pt's blood loss resulting in anemia.Loss of blood was clearly indicated in the medical record caused by the venous needle dislodging.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 rather it was caused by the pt picking at the tape holding the needle in place and causing it to dislodge.

Event Description

A user facility medwatch was received by the mfr reporting a pt's venous needle dislodged approximately two hours into her hemodialysis treatment and the machine did not alarm.Estimated blood loss was approximately 800ml.Prior to the dislodgement, the pt had been restless and repositioning in the chair.The pt then lost consciousness for approximately 40 seconds.Oxygen administered to pt at 15 liters and she was given 1000ml normal saline iv.Pt was stabilized.She was alert and oriented and ambulatory before leaving the clinic with emergency medical technician.Pt was then transported by ambulance to emergency room for further eval.Pt was admitted to hospital.Follow up was conducted with the facility's clinic manager (cm) and medical records were requested.According to the cm, the pt had been observed picking at the tape holding the venous needle in place prior to the dislodgement.According to medical records received, the pt was seen in the emergency room (er) where her initial hemoglobin (hgb) was 9.1 but the next morning, the hgb dropped to 6.5.There was no record of blood transfusion, however pt reported to the cm she received one (1) unit of blood.Discharge date was not given.On (b)(6) 2015 the pt was seen in the er for anemia.Hgb was 5.5.She did not have any active bleeding and was diagnosed with acute on chronic anemia likely secondary to the blood loss from an episode of vaginal bleeding the previous month and the blood from the venous needle dislodgement.She received three units of blood and her repeat hgb on (b)(6) 2015 was 10.5.Pt was discharged home on (b)(6) 2015.She continues on hemodialysis.According to the facility, no malfunction was alleged in conjunction with the device and the event of venous needle dislodgment.The device is not available for return to the mfr.Catalog and lot number were not known.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.An investigation of the lots delivered to the customer for the product in the three months prior to the event were reviewed and a lot number was not able to be determined.In addition, 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.

• Brand Name: FMC BLOODLINES
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA ; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial reynosa ; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st. ; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5077936
• MDR Text Key: 25887763
• Report Number: 8030665-2015-00416
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 54