MAUDE Adverse Event Report: CAREFUSION CAREFUSION; TUNNELED CATHETER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pneumothorax (2012); Respiratory Distress (2045); Discomfort (2330)

Event Date 01/25/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, c guided lung biopsy r anterior upper thorax: 0938 15.5 fr pleurx drain placed with immediate return of red tinged, clear fluid, attached to thoraseal and suction.Pt tolerating with no difficulty.Tube sutured in place with 2-0 nylon.Suction discontinued, draining to gravity only.Pt to notify this writer for any chest discomfort or need to cough.In (b)(6) 2017, pt presents from his volunteer position in lab.He is a, a, o x 3, visibly sob with walking, voice is hoarse.He states he is more sob than he was yesterday.He ambulates with steady gait, skin pale, w/d.Vs wnl.Lung sounds dim r upper and absent r lower, denies fevers or chills.Bandage to pleurx removed.No redness, drainage, or warmth to suture sites, denies pain.Pleurx cath attached to drainage bottle with immediate return of clear red fluid.After approx 750ml, pt began to have cough.Drainage stopped until cough resolved, then restarted at a slower drainage pace.Total of 1400ml was drained.Pt tolerated well with only occasional cough that resolved quickly.On (b)(6) 2017, arrived to radiology for drainage removal.Pleurx connected and started to drain dark amber fluid.At 1350, bottle stopped draining total out 700 ml.Disconnecting process and disposal.On (b)(6) 2017, returned for drain of pleurx.Arrived ambulatory with steady gait, skin pale w/d and resp with no visible problems.Able to walk and talk in full sentences.Vs wnl, no complaints.Daughter present, states she is unable to assist with home draining, but that her mother got too upset when here on monday, so she would like to watch the drainage.Has ct scan from hog that pt had done today.Chest x-ray today revealed pneumothorax which is felt to be related to faulty valve on distal end of the chest tube.

• Brand Name: CAREFUSION
• Type of Device: TUNNELED CATHETER
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 6311667
• MDR Text Key: 66913658
• Report Number: MW5067746
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 2.0 NYLON; SUCTION; THORASEAL
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Weight: 86