FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
Report
- Report Number
- 1820334-2025-00365
- Event Type
- Death
- Date Received
- April 9, 2025
- Date of Event
- March 15, 2025
- Report Date
- November 6, 2025
- Manufacturer
- COOK INC
- Product Code
- GBX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D4 - CATALOG #: C-PPD-1200-CHILDRENS-082694-IMH. G4 ¿ PMA/510(K) #: EXEMPT. H3 - DEVICE EVALUATED BY MFG? DEVICE NOT RETURNED TO MANUFACTURER. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
ADDITIONAL INFORMATION: H6 - ADDITIONAL ANNEX E CODE. CORRECTION: H6 - ANNEX G. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT A 12FR FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET WAS REQUIRED TO DRAIN PLEURAL FLUID FROM A 2-YEAR-OLD PEDIATRIC PATIENT. PRIOR TO DEVICE PLACEMENT, THE PATIENT WAS IN CRITICAL CONDITION, INTUBATED, AND BEING TREATED FOR SEPSIS AND PNEUMONIA. DURING THE PROCEDURE ON (B)(6) 2025, THE DEVICE WAS INSERTED INTO THE THIRD INTERCOSTAL SPACE, AND FLUID WAS SUCCESSFULLY ASPIRATED. THE PROCEDURE WENT SMOOTHLY WITH NO COMPLICATIONS, AND AN ADDITIONAL 150 ML OF FLUID WERE DRAINED AFTER THE CATHETER WAS PLACED. NO BLOOD IN THE FLUID, THE DRAIN, OR THE ENDOTRACHEAL TUBE WAS SEEN AT THIS TIME. A POST-PROCEDURE X-RAY WAS PERFORMED TO VERIFY CATHETER PLACEMENT, AND THE IMAGING CONFIRMED NORMAL PLACEMENT OF THE DEVICE. THREE HOURS AFTER THE DRAIN WAS PLACED, THE PATIENT BEGAN BLEEDING PROFUSELY FROM THEIR ENDOTRACHEAL TUBE AND FROM THE FUHRMAN DRAIN. THE PATIENT EXPERIENCED CARDIAC AND/OR RESPIRATORY ARREST AS RESULT AND LATER EXPIRED FROM THESE COMPLICATIONS. THE FAMILY OF THE PATIENT DECLINED AN AUTOPSY. IT SHOULD BE NOTED THAT THE COOK REPRESENTATIVE SPOKE TO THE PHYSICIAN. ¿SHE (THE PHYSICIAN) DESCRIBED THE PROCEDURE IN DETAIL, AND IT SOUND[ED] LIKE EVERYTHING WAS TEXTBOOK.¿ THE COOK REPRESENTATIVE IS UNAWARE OF ANY ADDITIONAL PROCEDURES THAT WERE COMPLETED PRIOR TO THE PLACEMENT OF THE CHEST TUBE. REVIEWS OF DOCUMENTATION INCLUDING THE QUALITY CONTROL AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY ANY POTENTIAL NON-CONFORMANCES PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH TO THE CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. THE PRODUCT LABELING WAS NOT REVIEWED AS THERE WAS NO REPORTED DEVICE FAILURE OR DEFICIENCY. BASED ON THE INFORMATION PROVIDED, NO DEVICE RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THE EVENT WAS DUE TO THE PATIENT¿S PRE-EXISTING CONDITIONS. IT WAS REPORTED THAT THE PATIENT WAS IN CRITICAL CONDITION WITH SEPSIS AND PNEUMONIA. IT IS POSSIBLE THAT THE PRE-EXISTING CONDITIONS OF THE PATIENT WERE IMPACTED BY THE PLACEMENT PROCEDURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
IT WAS REPORTED THAT A 12FR FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET WAS REQUIRED TO DRAIN PLEURAL FLUID FROM A 2-YEAR-OLD PEDIATRIC PATIENT. PRIOR TO DEVICE PLACEMENT, THE PATIENT WAS IN CRITICAL CONDITION, INTUBATED, AND BEING TREATED FOR SEPSIS AND PNEUMONIA. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE THIRD INTERCOSTAL SPACE, AND FLUID WAS SUCCESSFULLY ASPIRATED. THE PROCEDURE WENT SMOOTHLY WITH NO COMPLICATIONS, AND AN ADDITIONAL 150 ML OF FLUID WERE DRAINED AFTER THE CATHETER WAS PLACED. NO BLOOD IN THE FLUID, THE DRAIN, OR THE ENDOTRACHEAL TUBE WAS SEEN AT THIS TIME. A POST-PROCEDURE X-RAY WAS PERFORMED TO VERIFY CATHETER PLACEMENT, AND THE IMAGING CONFIRMED NORMAL PLACEMENT OF THE DEVICE. THREE HOURS AFTER THE DRAIN WAS PLACED, THE PATIENT BEGAN BLEEDING PROFUSELY FROM THEIR ENDOTRACHEAL TUBE AND FROM THE FUHRMAN DRAIN. THE PATIENT EXPERIENCED CARDIAC AND/OR RESPIRATORY ARREST AS RESULT AND LATER EXPIRED FROM THESE COMPLICATIONS. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
ADDITIONAL INFORMATION WAS PROVIDED ON 10APR2025. THE COOK REPRESENTATIVE IS UNAWARE OF ANY ADDITIONAL PROCEDURES THAT WERE COMPLETED PRIOR TO THE PLACEMENT OF THE CHEST TUBE. THE FAMILY OF THE PATIENT DECLINED AN AUTOPSY.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1665202 | FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET | GBX CATHETER, IRRIGATION | GBX | COOK INC | G55727 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 MO | Unknown | Death |