Device product
Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
Z-0427-2017
Product summary
- Event
- Event 75491
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38160 units
- Official record key
device-enforcement:Z-0427-2017
Official wording
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Code information: 3178532 3184461 3202001 3240576 3240578 3240583 3247915 3253198 3253199 3261706 3261707 3261708 3265284
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.