FDA Adverse Event Injury Summary report: N

KING SYSTEMS UNIVERSAL TRANSPORT COMPONENT

MDR report key: 76602 · Received March 18, 1997

Report

Report Number
76602
Event Type
Injury
Date Received
March 18, 1997
Date of Event
February 24, 1997
Report Date
March 7, 1997
Manufacturer
KING SYSTEMS CORP.
Product Code
CAI
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PT HAVING REVISION OF VENTRICULAR PERITONEAL SHUNT. AT END OF CASE, CRNA CALLED ANESTHESIOLOGIST INTO ROOM. PT HAD ALREADY BEEN REVERSED, WAS BEGINNING TO MOVE AROUND. SATS IN THE 90S, THEN DROPPED TO 80S SO ANESTHESIOLOGIST PREPARED TO VENTILATE PT. CRNA HANDED VENTILATION BAG TO HIM - IT WOULD NOT INFLATE. CRNA TURNED VENT BACK ON AND AT THIS POINT, ANESTHESIOLOGIST REQUESTED THE TRANSPORT CIRCUIT BE TURNED ON INSTEAD. STILL COULDN'T VENTILATE PT. ANESTHESIOLOGIST NOW SUSPECTED BILATERAL TENSION PENUMOTHORACES BUT CHANGED OUT ENDOTRACHEAL TUBE TO BE SURE IT WASN'T THE TUBE. PT NOW CYANOTIC; CAPILLARY REFILL OKAY. PT REINTUBATED BY ANESTHESIOLOGIST WHO CALLED FOR ASSISTANCE; ALSO CALLED FOR PEDIATRIC SURGEON. EPINEPHRINE PUT DOWN ET TUBE AND ALSO THRU IV. CHEST COMPRESSIONS GIVEN FOR 1-2 MINS TO CIRCULATE DRUGS. SURGEON PLACED ANGIOCATH WHICH FOGGED UP. CHEST X-RAY SHOWED PROFOUND PNEUMOTHORACES ON THE RIGHT. CHEST TUBES X 2 TO WATER SEALS WERE PLACED BY SURGEON AND PT SENT OT PACU FOR RECOVERY. PT HAD UNEVENTFUL RECOVERY BOTH FROM THE SHUNT REVISION AND THE PNEUMOTHORACES AND WAS DISCHARGED HOME 2/27/97 WITH APPROPRIATE FOLLOW-UP ARRANGED. UPON EXAM, THUMB SLIDE VALVE WAS FOUND TO BE DEFECTIVE IN THAT IT COULD NOT BE FULLY OPENED NOR FULLY CLOSED. PICTURES HAVE BEEN SENT TO MFR AND VALVE IS AVAILABLE FOR INSPECTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KING SYSTEMS UNIVERSAL TRANSPORT COMPONENT THUMB SLIDE VALVE CAI KING SYSTEMS CORP. * *

Patients

Seq Age Sex Outcome Treatment
1 6 MO Hospitalization| L| R