FDA Adverse Event
Malfunction
Summary report: N
CRONO FIVE 5MG/ML
MDR report key: 7851064
·
Received September 5, 2018
Report
- Report Number
- MW5079634
- Event Type
- Malfunction
- Date Received
- September 5, 2018
- Report Date
- August 21, 2018
- Manufacturer
- CANE' S. P. A. / INTRA PUMP INFUSION SYSTEMS
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
SPOKE TO PT, ONE OF HER CRONO PUMPS SN: (B)(4) DUE APRIL 2019 ALARMED FOR OCCLUSION LAST WEEK BUT SHE COULD NOT FIND ANY OBSTRUCTION, SO SHE WAS FORCED TO SWITCH TO HER BACK UP PUMP. A FEW DAYS LATER, SHE ATTEMPTED TO USE THE PUMP AGAIN, AND SHE WAS ABLE TO RUN THE INFUSION BUT WHEN IT WAS DONE, SHE TRIED TO REMOVE THE BATTERY TO RESET THE PUMP, BUT THE PUMP WAS NOT RESPONDING. SHE HAD TO INSERT AND REMOVE THE BATTERY 10 TIMES TO GET THE PUMP TO RESPOND. NO FURTHER INFO IS KNOWN. DATES OF USE: FROM (B)(6) 2014 TO CURRENT. DIAGNOSIS OR REASON FOR USE: PAH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 685748 | CRONO FIVE 5MG/ML | PUMP, INFUSION | FRN | CANE' S. P. A. / INTRA PUMP INFUSION SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |