ARROW PSI KIT: 6 FR
Report
- Report Number
- 9680794-2022-00397
- Event Type
- Death
- Date Received
- July 5, 2022
- Date of Event
- June 4, 2022
- Report Date
- June 8, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DYB
- PMA / PMN Number
- K780532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4).
QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
CUSTOMER REPORTS ON (B)(6) 2022, THE NURSE WAS ABLE TO ATTACH THE LEVEL 1 RAPID INFUSER EXTENSION TUBING TO THE EXTENSION TUBING OF THE PSI (PERCUTANEOUS SHEATH INTRODUCER), BUT WHEN SHE WENT TO REMOVE THE TUBING SHE WAS UNABLE TO REMOVE THE PSI EXTENSION TUBING FROM THE LEVEL 1 RAPID INFUSER TUBING. IT WAS REPORTED THIS CAUSED A 3-4 MINUTE DELAY FOR ADMINISTERING BLOOD PRODUCTS. CUSTOMER REPORTS THE TUBING HAD TO BE REMOVED BECAUSE THE PATIENT REQUIRED SINGLE DONOR PLATELETS THAT WERE NOT COMPATIBLE WITH THE RAPID INFUSER. THE PATIENT WAS A CPR IN PROGRESS. THE CENTRAL LINE WAS DISCONNECTED FROM THE SET AND REPLACED. THE PATIENT DIED ON (B)(6) 2022 FROM A TRAUMATIC BRAIN INJURY SECONDARY TO A ATV/MOTOR VEHICLE ACCIDENT. THE CUSTOMER REPORTED THE DEVICE WAS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.
CUSTOMER REPORTS ON (B)(6) 2022, THE NURSE WAS ABLE TO ATTACH THE LEVEL 1 RAPID INFUSER EXTENSION TUBING TO THE EXTENSION TUBING OF THE PSI (PERCUTANEOUS SHEATH INTRODUCER), BUT WHEN SHE WENT TO REMOVE THE TUBING SHE WAS UNABLE TO REMOVE THE PSI EXTENSION TUBING FROM THE LEVEL 1 RAPID INFUSER TUBING. IT WAS REPORTED THIS CAUSED A 3-4 MINUTE DELAY FOR ADMINISTERING BLOOD PRODUCTS. CUSTOMER REPORTS THE TUBING HAD TO BE REMOVED BECAUSE THE PATIENT REQUIRED SINGLE DONOR PLATELETS THAT WERE NOT COMPATIBLE WITH THE RAPID INFUSER. THE PATIENT WAS A CPR IN PROGRESS. THE CENTRAL LINE WAS DISCONNECTED FROM THE SET AND REPLACED. THE PATIENT DIED ON (B)(6) 2022 FROM A TRAUMATIC BRAIN INJURY SECONDARY TO A ATV/MOTOR VEHICLE ACCIDENT. THE CUSTOMER REPORTED THE DEVICE WAS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422032 | ARROW PSI KIT: 6 FR | INTRODUCER CATHETER | DYB | ARROW INTERNATIONAL LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death | LEVEL 1 RAPID INFUSER.| LEVEL 1 RAPID INFUSER. |