FDA Adverse Event Injury Summary report: N

SPONTANEOUS PNEUMOTHORAX ASPIRATION SET

MDR report key: 525359 · Received May 14, 2004

Report

Report Number
1820334-2004-00282
Event Type
Injury
Date Received
May 14, 2004
Date of Event
April 7, 2004
Report Date
April 14, 2004
Manufacturer
COOK INC.
Product Code
DXT
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PT PRESENTED WITH COMPLAINT OF DYSPOEA OF 1 HR. EXAMINATION FINDINGS INCLUDED SHORTNESS OF BREATH, APYREXIC. CXR REVEALED RIGHT BASAL PNEUMOTHORAX. RIGHT LOWER LOBE COLLAPSED FULLY, RIGHT UPPER LOBE TETHERED. DECIDED TO PLACE PLEUROCATH AND WILL NEED INTERCOSTAL CHEST DRAIN IF PNEUMOTHORAX FAILS TO RESOLVE. THE PLEUROCATH WAS INSERTED, UNDERWATER SEAL DRAIN ATTACHED AND NOTED TO BE BUBBLING AND OSCILLATING. CXR PERFORMED AT 14.10 HRS. INTERCOSTAL DRAIN OBSERVATION CHART NOTED AT 14.15 HRS: OSCILLATING, NO AIR LEAKS, NO DRAINAGE OF FLUID. AT 17.10 HRS, PT. WAS TRANSFERRED. AT 19.00 HRS, OBSERVATIONS WERE STABLE, INTERCOSTAL OBSERVATION CHART RECORDINGS UNCHANGED. CODE BLUE WAS CALLED AT 0.100 HRS. PT UNRESPONSIVE AND 400ML OF DRAINAGE WAS NOTED FROM INTERCOSTAL TUBE. THE PT HAD EMD, RESPONDED TO RESUSCITATION. URGENT MOBILE CXR ON WARD SUGGESTED AN ENLARGED HEART AND MEDIASTINUM, COMPARED TO PREVIOUS CXR. NO PNEUMOTHORAX OR HEMOTHORAX. RIGHT SIDED SUBCUTANEOUS EMPHYSEMA WAS NOTED TOGETHER WITH HYPOTENSION. A TRANSTHORACIC ECHO WAS PERFORMED. PT REVIEWED BY CARDIOTHORACIC TEAM AND TRANSFERRED TO OPERATION FOR DEFINITIVE CARE AND SUBSEQUENT ADMISSION TO ICU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SPONTANEOUS PNEUMOTHORAX ASPIRATION SET SPECIAL SET DXT COOK INC. NA F1522889

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Required Intervention