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

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

Patient Problems Air Embolism (1697); Respiratory Distress (2045)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although medical records were requested, none were received.Plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

During treatment, an inpatient user facility reported that a machine alarmed air detected in the line and air was visually observed by a hemodialysis nurse.The patient experienced immediate discomfort, and treatment was discontinued.The patient was turned on their side by the hemodialysis nurse and was administered oxygen.The patient rested for 15 minutes, and then was put on a the same machine with a new bloodline after an examination by a physician who stated that further medical intervention would not be required.A potential air embolism had occurred, but the patient was cleared for treatment and was not taken to the hospital.The patient completed treatment without any further issues on a new treatment set-up.The actual sample is not available and currently no further product information is available.

Manufacturer Narrative

The device was not returned nor was a companion sample available to the manufacturer for physical evaluation.No malfunction was confirmed during evaluation of the alternate samples.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 bloodline tubing sets shipped to this account within the selected time frame.A records review was performed on each identified 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.

• Brand Name: FMC BLOODLINES
• 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: 5505203
• MDR Text Key: 40531656
• Report Number: 8030665-2016-00122
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 91