FDA Adverse Event
Death
Summary report: N
AGB TRIPLE LUMEN
MDR report key: 645084
·
Received November 2, 2005
Report
- Report Number
- 1036844-2005-00084
- Event Type
- Death
- Date Received
- November 2, 2005
- Date of Event
- September 15, 2005
- Report Date
- October 31, 2005
- Manufacturer
- ARROW INTERNATIONAL, INC.
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT PT PRESENTED TO ER AND QUICKLY STOPPED BREATHING AND HAD NO HEARTBEAT. PHYSICIAN PREPARED FOR A 3-L CVC INSERTION. HE PLACED CATHETER SEEMINGLY IN VENOUS SYSTEM. AFTER TRANSFER TO ICU, ICU NURSE NOTICED BRIGHT RED BLOOD BACKING UP IN TUBING. IV DRUGS (LEVOPHED AND NSS) WERE STOPPED IMMEDIATELY. ARTERIAL BLOOD GASES (ABGS) WERE DRAWN. PO2 NOTED AS 300, INDICATING LINE HAD BEEN INSERTED INTO ARTERIAL SYSTEM. CVC WAS THEN CHANGED TO AN ARTERIAL LINE BY PHYSICIAN. PATIENT CONDITION CONTINUED TO DECLINE AND SHE EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AGB TRIPLE LUMEN | ARROWG+ARD CATHETER PRODUCTS | DQO | ARROW INTERNATIONAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death |