MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for CRONO CRONO PUMP manufactured by Cane S. P. A..
[113162174]
Obc placed to pt regarding crono issues. States sn# (b)(4). 13 reset itself during the day yesterday and piston retracted back to starting position; states this may have caused the tubing to tug but only noticed that the piston. "reset" itself because there was some blood in her tubing. Pt performed the emergency hickman procedure on herself to ensure there wasn't any clots in her tubing. She restarted infusion using her backup pump and states she forgot to call for a replacement pump. Advised author will send out replacement crono pump and have team f/u during business hours for extra supplies. Pt (b)(6). Programmed crono pump sn# (b)(4). 15 (due 06/19/2019) to rate 380micro/hr. Dose or amount: 97ng/kg/min, frequency: q48hours, route: iv. Dates of use: from (b)(6) 2011 to ongoing. Diagnosis or reason for use: pah.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078190 |
| MDR Report Key | 7654523 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-06-25 |
| Date Added to Maude | 2018-07-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRONO |
| Generic Name | PUMP, INFUSION |
| Product Code | FEN |
| Date Received | 2018-06-29 |
| Model Number | CRONO PUMP |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CANE S. P. A. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |