MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for SAPPHIRE INFUSION PE-LINED LIGHT-RESISTANT TUBING ORANGE 115.8X0.6IN 347932 manufactured by Icu Medical, Inc..
[177581977]
Orange sapphire iv tubing cracked. The pump alarmed "air in line" and when disconnecting tubing from pump, it was wet. When i unclamped the tubing, i noted fluid shooting out of a crack in the tubing just below the cassette in the solid orange tubing. Tubing had to be replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9664503 |
| MDR Report Key | 9664503 |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-25 |
| Report Date | 2020-01-03 |
| Date Reported to FDA | 2020-01-03 |
| Date Reported to Mfgr | 2020-02-04 |
| Date Added to Maude | 2020-02-04 |
| 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 | SAPPHIRE INFUSION PE-LINED LIGHT-RESISTANT TUBING ORANGE 115.8X0.6IN |
| Generic Name | ACCESSORIES, PUMP, INFUSION |
| Product Code | MRZ |
| Date Received | 2020-02-04 |
| Catalog Number | 347932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | 600 N FIELD DR LAKE FOREST IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |