OLSTEN
Report
- Report Number
- 1220894-1999-00005
- Event Type
- Malfunction
- Date Received
- July 21, 1999
- Date of Event
- January 11, 1999
- Manufacturer
- MICROMED
- Product Code
- FPA
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
1/11/99 SPOKE WITH PT ABOUT TUBING, SHE STATES THAT SHE HAS HAD SOME TUBING THAT DID NOT CONNECT WITH HER CATHETER VERY WELL. SHE ALSO STATES THAT BLOOD BACK-FLOWS INTO HER LINE WHEN SHE IS CHANGING HER CASSETTED. PT WAS ASKED IF SHE IS USING A CLAVE, SHE STATED THAT SHE IS NOT, BUT WOULD BE INTERESTED IN TRYING THEM OUT PT WAS ALSO ASKED TO ATTEMPT TO KEEP TRACK OF LOT NUMBERS ON THE TUBING PACKAGE, SO THAT CO MAY BE ABLE TO DETERMINE A TREND. SHE VERBALIZED AND UNDERSTOOD AND WAS THANKFUL FOR THE RETURN CALL.
ON 2/22/99 1140 CENTRAL STANDARD TIME: TUBING PROBLEM. PT CALLED TO SAY THAT ON SATURDAY HIS TUBING HAD A MICRO CRACK AND LEAKED WHERE HE CONNECTS TO HIS CATHETER. IT ALSO HAPPENED ABOUT 2 WEEKS AGO. HE WANTED TO TALK TO SOMEONE ABOUT IT.
ON 3/8/99 1030 CENTRAL STANDARD TIME: RN RECEIVED A CALL FROM PT'S MOTHER ABOUT LEAKING TUBING. HAS BEEN LEAKING WHERE IT ATTACHES TO CLAVE.
ON 5/15/99 RN RECEIVED A CALL - LEAKING TUBING. RECEIVED A CALL FROM PT STATING HIS PUMP TUBING IS LEAKING. WALKED PT THROUGH PRIMING AND CHANGING TUBING. AT END OF CALL. FLOLAN WAS INFUSING WITHOUT INCIDENT. PT DOES NOT HAVE LOT # OF LEAKY TUBING.
ON 4/8/99 RN RECEIVED A CALL OF TUBING LEAKING AND HI PRESSURE ALARM. AT 1350 CENTRAL STANDARD TIME PT CALLED STATING THAT TUBING WAS LEAKING FROM WHERE TUBING CONNECTS TO HUB OF CATH. PT CHANGED TUBING BUT HE WAS UNSURE HOW LONG HE WAS OFF THE FLOLAN. AFTER TUBING CHANGE HI PRESSURE ALARM WENT OFF. RN ASKED PT TO ADJUST TUBING IN PUMP AND TO MAKE SURE THAT THERE ARE NO KINKS IN TUBING. HI PRESSURE ALARM RESOLVED. PT STATING THAT HE FEELS NAUSEATED AND DIZZY. WIFE WILL BE WITH PT AND WILL CALL BACK IF HE IS FEELING WORSE.
ON 6/1/99 - TUBING PROBLEMS. A CALL FROM RN REPORTING PT HAD THREE INCIDENTS OF FAULTY TUBING IN WHICH WHILE CHANGING BECAME LIGHT HEADED, NOW WILL CHECK ALL TUBINGS BEFORE ATTEMPTING TO USE. FAULTY LOT # IS M10C9.
ON 5/8/99 12:27 PM CENTRAL STANDARD TIME, PT EXT TUBING CAME LOOSE IN THE "NOC". HE WAS SOB WHEN HE CALLED AND ADMITTED TO BEING VERY ANXIOUS. HE NOTICED THE LOOSE CONNECTION WITH A SPOT ON THE BED. HE DID KNOW HOW MUCH MEDICATION HE HAD LOST. HE HAD RECONNECTED THE EXTENSION TUBING WHEN HE CALLED AND THE PUMP WAS RUNNING. HE WAS FEELING LESS SOB. HE WILL RELAX FOR THE NEXT 30 MIN AND CALL HIS MD IF HE IS NOT FEELING BETTER.
ON 5/7/99 RN ON CALL. PT HAVING DIFFICULTY WITH TUBING LEAKING. AT 0620 CENTRAL STANDARD TIME, PT CALLED AND STATED THAT SHE HAS CHANGED THE TUBING TWO TIMES AND HER GROSHONG/TUBING CONNECTION CONTINUED TO LEAK. PT STATED THAT THIS HAPPENED ONE TIME BEFORE AND SHE ATTEMPTED TO FLUSH LINE. DISCOVERED LINE WILL NOT FLUSH.
ON 6/18/99 0935 CENTRAL STANDARD TIME PT'S HUSBAND CALLED TO SAY THAT HE HAS HAD SEVERAL DEFECTIVE TUBING THAT EITHER LEAK OR WILL NOT THREAD CORRECTLY TO THE CATH. HE REQUESTED 10 TUBINGS TO REPLACE THE ONES THAT AREA DEFECTIVE. TALKED WITH THE PUMP GUY WHO SAID HE WOULD CALL THE HUSBAND AND DISCUSS THE PROBLEM FURTHER.
SENDIMNG CALL - TAGS TO RECOVER LEAKING EXTENSION SET.
ON 6/2/99 PT HAS EXT TUBING THAT DOES NOT FIT. AT 1310 CENTRAL STANDARD TIME PT HAS BEEN THROWING THEM AWAY. NOW ONLY HAS THREE AND NEEDS MORE BY FRIDAY.
6/15/99 - PT HAVING PROBLEMS WITH LOOSE TUBING - WILL NEED TUBING. AT 0300 CENTRAL STANDARD TIME, PT CALLED AND STATED SHE HAS BEEN THROUGH AT LEAST 5 TUBINGS AND THEY ALL ARE LOOSE WHEN HOOKED UP TO THE HUB OF HER HICKMAN. ABLE TO SECURE WITH TAPE, THEY ARE NOT LEAKING BUT LOOSE FEELING WHEN SCREWING THEM ON. PT WILL FOLLOW UP IN THE AM.
ON 5/17/99 9:00 AM, CENTRAL STANDARD TIME, EXTENSION TUBING NOT THREADING. A CALL FROM PT'S SPOUSE REPORTING PT HAS HAD 3 INCIDENTS OF THE MALE END OF THE EXT TUBING NOT THREADING, HAS DISCARDED THESE. REPORTS HAS "EXTRA" WILL NOT NEED ADD'L SHIPMENT BEFORE REORDER. INSTRUCTED TO CALL WITH ANY FURTHER INCIDENTS.
ON 4/27/99, AT 1800, FAULTY EXTENSION TUBING. PT'S WIFE CALLED TO REPORT THAT THEY HAD TRIED TO ATTACH SEVERAL EXTENSION TUBINGS AND THAT THEY WERE UNABLE TO CONNECT ANY OF THEM SATISFACTORILY. KEPT CLINIC ON PHONE WHILE THEY FINALLY FOUND ONE WHICH WOULD CONNECT. PT'S WIFE FEELS THEY MAY HAVE A DEFECTIVE LOT. RN TOLD THEM CLINIC WOULD HAVE NEW SHIPMENT OF TUBING SENT.
ON 4/13/99. PT TUBING IS LEAKING. PT TUBING NOT THE GROSHONG IS LEAKING. THE LUER LOCK DOES NOT FIT TIGHTLY TO THE GROSHONG AND AS A RESULT LEAKS. PLEASE SENT PT NEW BATCH OF TUBING AND ALSO ANOTHER CADD-BAG/POUCH. HE PERFERS THE OLDER ONE IF POSSIBLE.
ON 6/18/99 1024 CENTRAL STANDARD TIME - SPOKE WITH THE PUMP MAN ABOUT THE EARLIER NOTED TUBING CONNECTION PROBLEM. HE SAID HE WOULD CALL THE PT.
ON 6/21/99 1320 CENTRAL STANDARD TIME - PT CALLED TO LET CLINIC KNOW THAT HE HAD DIFFICULTY WITH 4 MORE TUBING WITH THE CONNECTION TO THE CATH BEING LOOSE. HE WANTED TO KNOW IF HE WAS SUPPOSED TO SENT IN THESE TUBING FOR INSPECTION AS WELL. RN TOLD HIM TO HOLD ONTO THEM FOR A WEEK AND IF HE HAD NOT HEARD FROM THE PUMP MAN TO THROW THEM AWAY. LEFT VOICE MAIL ABOUT THIS FOR THE PUMP MAN.
ON 2/18/99; 1750 CENTRAL STANDARD TIME; TUBING LEAKING. PT CALLED STATING THAT ABOUT 8 OF HER TUBINGS HAVE LEAKED AT C.L. CONNECTION. STATES SHE TOOK A MAGNIFYING GLASS TO ONE AND IT HAD A PINHOLE IN IT. SHE HAS THROWN THOSE AWAY BUT WILL SAVE ANY FUTURE DEFECTIVE TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLSTEN | EXTENSION SET W/MICRON FILTER | FPA | MICROMED | NA | 9C39M, 9C01M, UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death| L| O | ||
| 10 | UNKNOWN | |||
| 11 | UNKNOWN | |||
| 12 | UNKNOWN | |||
| 13 | UNKNOWN | |||
| 14 | UNKNOWN | |||
| 15 | UNKNOWN | |||
| 16 | UNKNOWN | |||
| 17 | UNKNOWN | |||
| 18 | UNKNOWN | |||
| 2 | UNKNOWN | |||
| 3 | UNKNOWN | |||
| 4 | UNKNOWN | |||
| 5 | UNKNOWN | |||
| 6 | UNKNOWN | |||
| 7 | UNKNOWN | |||
| 8 | UNKNOWN | |||
| 9 | UNKNOWN |