FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

Report

Report Number: 1820334-2015-00795
Event Type: Death
Date Received: December 3, 2015
Date of Event: August 5, 2015
Report Date: November 6, 2015
Manufacturer: COOK INC
Product Code: GBX
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GB
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE EVENT IS CURRENTLY UNDER INVESTIGATION.

Additional Manufacturer Narrative · 1

(B)(4). EVENT EVALUATION A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. THE DEVICE IS PACKAGED WITH IFU. THE IFU STATES THE INTENDED USE TO BE "THE FUHRMAN PLEURAL/PNEUMOCARDIAL DRAINAGE SET (PPD-) IS INTENDED FOR EVACUATION OF AIR FROM THE PERICARDIAL SAC OR DRAINAGE OF AIR OR FLUID FROM THE PLEURAL SPACE. THE PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. STANDARD SELDINGER TECHNIQUE FOR PLACEMENT OF NEEDLES, WIRE GUIDES, DILATORS AND CATHETERS SHOULD BE EMPLOYED. IT ALSO STATES UNDER INSTRUCTIONS FOR USE STEP 4, "GENTLY ADVANCE NEEDLE INTO THE POSITIVE PRESSURE AREA." STEP 5, "VERIFY PLACEMENT INTO THE PLEURAL OR PERICARDIAL SPACE BY ASPIRATION OF AIR OR FLUID INTO SYRINGE. REMOVE SYRINGE ONCE PLACEMENT IS VERIFIED." THE EVENTS STATED IN THE CORONERS' REPORT INDICATE THAT DRAINAGE WAS SUCCESSFULLY ACHIEVED ON MULTIPLE PLACEMENTS. THE REPORT ALSO STATES, "ON (B)(6) 2015, THE BABY WAS NOTED TO HAVE RECURRENT EPISODES OF OXYGEN DESATURATIONS WHICH IMPROVED WHEN AIR WAS ASPIRATED OUT OF THE EXISTING CHEST DRAINS. A SECOND DRAIN WAS INSERTED AND SOON AFTER, BLOOD WAS OOZING OUT OF THE CHEST DRAIN. A TRIAL OF FLOW SEAL INSTALLATION WAS GIVEN INTO THE LEFT PNEUMOTHORAX TO CONTROL THE BLEEDING. THE BABY CONTINUED TO HAVE SIGNIFICANT BLEEDING AND FURTHER DETERIORATED AND DIED AT 22.45 HRS ON (B)(6) 2015." THE REPORT ALSO STATES THAT "THE CHEST DRAIN IN HIS LOWER CHEST ALSO LOOPED FULL CIRCLE AND DAMAGED ONE OF THE LARGE PULMONARY ARTERY BRANCH..." AND "... THE PULMONARY ARTERY WAS INADVERTENTLY DAMAGED AND RESULTED IN FATAL CONSEQUENCES." BASED ON THIS STATEMENT, THE PATIENT'S NOTED EXTREME PREMATURITY, EXTREME LOW LEVELS OF THE CLOTTING PROTEIN FIBRINOGEN AND RESPIRATORY DISTRESS SYNDROME ARE NOTED CONTRIBUTING FACTORS TO THE OUTCOME OF THE CASE. THE CORONERS' OFFICE RULED THE DEATH ACCIDENTAL BUT SUGGESTED THAT THE DESIGN OF THE DRAIN SHOULD BE CONSIDERED AS IT RELATES TO USE OF THE DEVICE PARTICULARLY IN SMALL/PREMATURE BABIES. IT SHOULD BE NOTED THAT THERE ARE ALTERNATIVE DEVICES THAT MAY HAVE BEEN BETTER SUITED FOR THIS CASE. WE HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. A HEALTH RISK ASSESSMENT (HRA) WAS USED TO ASSESS RISK AND DETERMINE IF ADDITIONAL RISK MITIGATION ACTIVITIES ARE REQUIRED. THIS IS BASED ON THE PROBABILITY OF THE HAZARDOUS SITUATION LEADING TO HARM AS WELL AS THE SEVERITY OF THE HARM. PER THE CONCLUSION OF THE HRA, IT WAS DETERMINED THAT ADDITIONAL RISK REDUCTION MEASURES ARE NOT REQUIRED AT THIS TIME. WE HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

Description of Event or Problem · 1

THE CHEST DRAIN IN THE UPPER CHEST LOOPED FULL CIRCLE AROUND THE LUNG LOBE AND STRANGLED THE BRONCHI, HOWEVER THIS IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH. ON (B)(6) 2015, A PREMATURE BABY WAS BORN AT A GESTATION OF (B)(6) WEEKS. HIS MOTHER HAD SUFFERED FROM A PLACENTA ABRUPTION WHICH CAUSED THE PREMATURE BIRTH. ON (B)(6) 2015, DUE TO HIS IMMATURE LUNGS THE BABY DEVELOPED A LEFT SIDED LARGE PNEUMOTHORAX WHICH REQUIRED A CHEST DRAIN INSERTION, THIS DRAIN RESOLVED THE PNEUMOTHORAX AND THE DRAIN WAS REMOVED ON (B)(6) 2015. LATER THE SAME DAY THE CHEST DRAIN HAD TO BE RE-INSERTED INTO THE UPPER CHEST DUE TO THE RE-ACCUMULATION OF PNEUMOTHORAX. ON (B)(6) 2015 THE BABY SIGNIFICANTLY DETERIORATED AND REQUIRED ANOTHER CHEST DRAIN TO BE INSERTED INTO HIS LOWER CHEST AS A SINGLE DRAIN WAS FAILING TO RESOLVE THE PNEUMOTHORAX. ON (B)(6) 2015 THE SECOND CHEST DRAIN WAS REPLACED TO IMPROVE DRAINAGE. ON (B)(6) THE CHEST DRAIN IN THE LOWER CHEST CAME OUT BUT WAS NOT REPLACED AS THE BABY WAS CLINICALLY STABLE. FROM (B)(6) THERE WERE REPEATED EPISODES OF CLINICAL DETERIORATION. ON (B)(6) 2015 THE BABY WAS NOTED TO HAVE RECURRENT EPISODES OF OXYGEN DESATURATIONS WHICH IMPROVED WHEN AIR WAS ASPIRATED OUT OF THE EXISTING CHEST DRAINS. A SECOND DRAIN WAS INSERTED AND SOON AFTER BLOOD WAS OOZING OUT OF THE CHEST DRAIN. A TRIAL OF FLOW SEAL INSTALLATION WAS GIVEN INTO THE LEFT PNEUMOTHORAX TO CONTROL THE BLEEDING. THE BABY CONTINUED TO HAVE SIGNIFICANT BLEEDING AND FURTHER DETERIORATED AND DIED AT 22.45 HRS ON (B)(6) 2015. THE BABY WAS ALSO FOUND TO HAVE EXTREMELY LOW LEVELS OF THE CLOTTING PROTEIN, FIBRINOGEN. THE CHEST DRAIN IN HIS UPPER CHEST LOOPED FULL CIRCLE AROUND THE LUNG LOBE AND STRANGLED THE BRONCHI, HOWEVER THIS IS UNLIKELY TO HAVE CONTRIBUTED TO HIS DEATH (1820334-2015-00787). THE CHEST DRAIN IN HIS LOWER CHEST ALSO LOOPED FULL CIRCLE AND DAMAGED ONE OF THE LARGE PULMONARY ARTERY BRANCH LEADING TO MASSIVE THORACIC BLEEDING. AS A RESULT OF THE DRAINING PROCEDURE CARRIED OUT THE PULMONARY ARTERY WAS INADVERTENTLY DAMAGED AND THIS RESULTED IN FATAL CONSEQUENCES (1820334-2015-00795).

Description of Event or Problem · 1

THE CHEST DRAIN IN THE UPPER CHEST LOOPED FULL CIRCLE AROUND THE LUNG LOBE AND STRANGLED THE BRONCHI, HOWEVER THIS IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH. ON (B)(6) 2015, A PREMATURE BABY WAS BORN AT A GESTATION OF (B)(6). HIS MOTHER HAD SUFFERED FROM A PLACENTA ABRUPTION WHICH CAUSED THE PREMATURE BIRTH. ON (B)(6) 2015, DUE TO HIS IMMATURE LUNGS THE BABY DEVELOPED A LEFT SIDED LARGE PNEUMOTHORAX WHICH REQUIRED A CHEST DRAIN INSERTION, THIS DRAIN RESOLVED THE PNEUMOTHORAX AND THE DRAIN WAS REMOVED ON (B)(6) 2015. LATER THE SAME DAY THE CHEST DRAIN HAD TO BE RE-INSERTED INTO THE UPPER CHEST DUE TO THE RE-ACCUMULATION OF PNEUMOTHORAX. ON (B)(6) 2015 THE BABY SIGNIFICANTLY DETERIORATED AND REQUIRED ANOTHER CHEST DRAIN TO BE INSERTED INTO HIS LOWER CHEST AS A SINGLE DRAIN WAS FAILING TO RESOLVE THE PNEUMOTHORAX. ON (B)(6) 2015 THE SECOND CHEST DRAIN WAS REPLACED TO IMPROVE DRAINAGE. ON (B)(6) THE CHEST DRAIN IN THE LOWER CHEST CAME OUT BUT WAS NOT REPLACED AS THE BABY WAS CLINICALLY STABLE. FROM (B)(6) THERE WERE REPEATED EPISODES OF CLINICAL DETERIORATION. ON (B)(6) 2015 THE BABY WAS NOTED TO HAVE RECURRENT EPISODES OF OXYGEN DESATURATIONS WHICH IMPROVED WHEN AIR WAS ASPIRATED OUT OF THE EXISTING CHEST DRAINS. A SECOND DRAIN WAS INSERTED AND SOON AFTER BLOOD WAS OOZING OUT OF THE CHEST DRAIN. A TRIAL OF FLOW SEAL INSTALLATION WAS GIVEN INTO THE LEFT PNEUMOTHORAX TO CONTROL THE BLEEDING. THE BABY CONTINUED TO HAVE SIGNIFICANT BLEEDING AND FURTHER DETERIORATED AND DIED AT 22.45 HRS ON (B)(6) 2015. THE BABY WAS ALSO FOUND TO HAVE EXTREMELY LOW LEVELS OF THE CLOTTING PROTEIN, FIBRINOGEN. THE CHEST DRAIN IN HIS UPPER CHEST LOOPED FULL CIRCLE AROUND THE LUNG LOBE AND STRANGLED THE BRONCHI, HOWEVER THIS IS UNLIKELY TO HAVE CONTRIBUTED TO HIS DEATH (1820334-2015-00787). THE CHEST DRAIN IN HIS LOWER CHEST ALSO LOOPED FULL CIRCLE AND DAMAGED ONE OF THE LARGE PULMONARY ARTERY BRANCH LEADING TO MASSIVE THORACIC BLEEDING. AS A RESULT OF THE DRAINING PROCEDURE CARRIED OUT THE PULMONARY ARTERY WAS INADVERTENTLY DAMAGED AND THIS RESULTED IN FATAL CONSEQUENCES (1820334-2015-00795).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
795232	FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET	GBX CATHETER, IRRIGATION	GBX	COOK INC	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	8 DA		Death