FDA Adverse Event
Other
Summary report: N
MAIN PUMP TUBING
MDR report key: 1001412
·
Received February 20, 2008
Report
- Report Number
- 1220246-2008-00011
- Event Type
- Other
- Date Received
- February 20, 2008
- Date of Event
- January 16, 2008
- Report Date
- January 21, 2008
- Manufacturer
- ARTHREX, INC.
- Product Code
- HRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER 8 MINS INTO A SHOULDER REPAIR, THE PT'S SHOULDER BECAME DISTENDED. THE SHOULDER CONTINUED TO GET BIGGER THROUGHOUT THE CASE. THE SURGEON HAD STARTED THE CASE WITH PUMP SETTINGS AT 40MMHG AND 70% FLOW. THE PUMP WAS TURNED DOWN TO 20MMHG AND 70% FLOW. BLISTERS WERE REPORTED AROUND THE PORTAL SITES FROM THE CANNULAS AGAINST THE SKIN. THE SURGERY WAS DELAYED OVER 30 MINS. FURTHER COMMUNICATION INDICATES THE BLISTERS HAVE RESOLVED AND THE PT IS IN GOOD CONDITION. NO FURTHER PT INFO WAS PROVIDED. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAIN PUMP TUBING | TUBING SYSTEM | HRX | ARTHREX, INC. | NA | 003265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | AR-6400/ UNK SN |