MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-24 for SAPPH 20DPM CONV RC CLAVE-Y 296CM 163279255 manufactured by Icu Medical Costa Rica Ltd..
[186809562]
(b)(6). The customer indicated that a device is available to return for evaluation; it has not been received.
Patient Sequence No: 1, Text Type: N, H10
[186809603]
The date of the event is unknown. The event involved a sapphire tpn tubing set that was reported to under-deliver an unspecified medication. The customer stated that there was around thirty milliliters (ml) in the bag, while before everything was delivered with the same programming.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2020-00020 |
| MDR Report Key | 9627347 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-24 |
| Date of Report | 2019-12-27 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2020-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTOPHER ZANONI |
| Manufacturer Street | 600 N. FIELD DR. |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2247062300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAPPH 20DPM CONV RC CLAVE-Y 296CM |
| Generic Name | ACCESSORIES, PUMP, INFUSION |
| Product Code | MRZ |
| Date Received | 2020-01-24 |
| Catalog Number | 163279255 |
| Lot Number | 856295H |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |