FDA Adverse Event Injury Summary report: N

PLEURX DRAINAGE KIT

MDR report key: 7556592 · Received May 30, 2018

Report

Report Number
MW5077552
Event Type
Injury
Date Received
May 30, 2018
Date of Event
May 29, 2018
Report Date
May 29, 2018
Manufacturer
CAREFUSION 2200, INC.
Product Code
PNG
UDI-DI
10885403090707
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY FATHER-IN-LAW LIVES IN OUR HOME AND MY HUSBAND AND I ARE HIS PRIMARY CAREGIVERS. HE HAS PLEURAL EFFUSION AND THE CAUSE IS UNKNOWN TO DOCTORS. WE CURRENTLY PROVIDE DAILY CARE, DRAINING FLUID FROM AROUND HIS LUNGS USING A PLEURX DRAINAGE KIT WITH A 1000 ML VACUUM BOTTLE. HIS AVERAGE DRAINAGE VOLUME HAS BEEN 750 - 1000 ML PER DAY. OVER THE PAST FEW WEEKS, WE'VE NOTICED DAYS WHEN THERE WERE LOWER VOLUMES, BUT WHEN WE WENT TO EMPTY THE BOTTLE, THERE WAS NO PRESSURE REMAINING IN THE BOTTLE. TWO DAYS AGO, THE BOTTLE STOPPED FLOWING AT 500 ML. I CHECKED THE BOTTLE AND THERE WAS NO PRESSURE REMAINING. BECAUSE MY FATHER-IN-LAW WAS SHORT OF BREATH, I OPENED ANOTHER BOTTLE AND DRAINED ANOTHER 350 ML. TODAY, THE BOTTLE STOPPED AT 750 ML AND THERE WAS NO PRESSURE REMAINING. I COULDN'T USE ANOTHER BOTTLE BECAUSE WE WOULD RUN OUT BEFORE ANOTHER SUPPLY WAS DELIVERED, BUT HE WAS STILL SHORT OF BREATH. WE ARE ONLY SENT 10 BOTTLES AT A TIME AND HAVE ZERO EXTRA SUPPLIES. (B)(6) MEDICAL SUPPLIES ALSO WILL ONLY SHIP ON THE DAY BEFORE YOU ARE ABOUT TO RUN OUT OF SUPPLIES - THEY SAY BECAUSE OF MEDICARE RULES. THIS RECENT PATTERN IS VERY CONCERNING. MY FATHER-IN-LAW IS NOT IN GOOD HEALTH. DEFECTIVE BOTTLES THAT ARE NOT ADEQUATELY PRESSURIZED TO REMOVE THE FLUID FROM AROUND HIS LUNGS COULD ENDANGER HIS LIFE. AT THE SAME TIME, WE ARE MUCH MORE FORTUNATE THAN MOST PEOPLE. I'M HOME WITH MY FATHER-IN-LAW DURING THE DAY AND MY HUSBAND IS A PHYSICIAN. WE FIGURED OUT THAT THE LOW VOLUMES WERE BECAUSE THE BOTTLES WERE DEFECTIVE. OTHER INDIVIDUALS OR FAMILIES MAY NOT BE SO FORTUNATE! CAREFUSION/PLEURX ALSO CHANGED THE FOAM MATERIAL THEY USE AS THE BARRIER BETWEEN THE SKIN AND THE ADHESIVE. IT FEELS/LOOKS LIKE LOWER DENSITY/QUALITY FOAM. I HIGHLY DOUBT THAT SAVINGS WERE PASSED ALONG TO MEDICARE OR PATIENTS. MY HUSBAND REPORTED THE DEFECTIVE BOTTLES TO (B)(6) MEDICAL TODAY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
394148 PLEURX DRAINAGE KIT PERITONEAL, DRAINAGE CATHETER PNG CAREFUSION 2200, INC. 50-7510 1000ML 0001219858 10885403090707
394149 PLEURX DRAINAGE KIT PERITONEAL, DRAINAGE CATHETER PNG CAREFUSION 2200 INC. 50-7510 1000ML 0001219858 10885403090707

Patients

Seq Age Sex Outcome Treatment
1 88 YR