MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for SPINNING SPIROS CH2000S manufactured by Icu Medical, Inc..
[184079620]
At end of the chemotherapy infusion it was noted that the patients gown was wet near the port site. It looked at though the spiros cap was leaking on the distal end when it connected to the iv luerlock. The chemotherapy was stopped and spiros cap was checked to see if it was tightened and it was. The end that was connected to the iv line was spinning as intended. The issue was at the end that connects to the iv. I restarted the chemo flush but noticed that it continued to leak a small amount. I flushed the line and discarded the chemo line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9853246 |
| MDR Report Key | 9853246 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-11-13 |
| Report Date | 2020-02-04 |
| Date Reported to FDA | 2020-02-04 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | SPINNING SPIROS |
| Generic Name | CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION |
| Product Code | ONB |
| Date Received | 2020-03-19 |
| Model Number | CH2000S |
| Catalog Number | CH2000S |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | 951 CALLE AMANECER SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |