FDA Adverse Event
Malfunction
Summary report: N
CRONO FIVE PUMP
MDR report key: 7734821
·
Received July 30, 2018
Report
- Report Number
- MW5078704
- Event Type
- Malfunction
- Date Received
- July 30, 2018
- Date of Event
- July 7, 2018
- Report Date
- July 7, 2018
- Manufacturer
- CANE S.P.A MEDICAL TECHNOLOGIES
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT CALLED STATING THAT SHE WAS HAVING PROBLEMS WITH BOTH CRONO PUMPS (SN (B)(4), MNT DUE (B)(6) 2018 AND SN (B)(4), MNT DUE (B)(6) 2018). PT STATES THAT SHE WAS GETTING AN OCCLUSION ALARM AND HAD TO CHANGE OUT BOTH PUMPS BUT ONE WAS ABLE TO START RUNNING AGAIN. PT STATES THAT THE MEDICATION WAS OFF FOR A "FEW HOURS" BUT RESTARTED AND HAS NOT HAD ANY WORSENING SYMPTOMS. NO OTHER INFO KNOWN. DEVICE MALFUNCTION: THE REPORTED PRODUCT FAULT OCCURRED WHILE IN USE WITH A PT. THE PRODUCT ISSUE DID NOT CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY. WE REPLACED THE DEVICE. DOSE OR AMOUNT: 70.1 NG/KG/MIN, FREQUENCY: CONTINUOUS, ROUTE: IV. DATES OF USE: FROM (B)(6) 2016 TO PRESENT. DIAGNOSIS OR REASON FOR USE: PAH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575301 | CRONO FIVE PUMP | CRONO FIVE PUMP | FRN | CANE S.P.A MEDICAL TECHNOLOGIES | |||
| 575302 | CRONO FIVE PUMP | CRONO FIVE PUMP | FRN | CANE S.P.A MEDICAL TECHNOLOGIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |