MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-23 for NDEHP SAPPHIRE MIC NV +1.2FLTR 163350402 manufactured by Icu Medical Costa Rica Ltd..
[144990769]
The customer is unknown; therefore, the device will not return for evaluation. The reported complaint cannot be confirmed without the returned sample. A device history review (dhr) could not be completed due to the unknown lot number.
Patient Sequence No: 1, Text Type: N, H10
[144990770]
User facility voluntary medwatch report mw5085386 was received that stated the following:? Our infusion pharmacy has had many recurring issues with icu medical sapphire infusion pumps and tubing sets. The tubing sets are leaking at the filters (both the 1. 2 micron filter and the 0. 22 micron filter sets are having this issue). The issue has been reported to icu medical multiple times with no action being taken other than? Investigation?.? It was additionally indicated that there was no adverse event, but there was a serious injury that required intervention. The event occurred on an unspecified date. No additional information is available as there is no contact information provided. This report reflects the sapphire tubing set with a 1. 2 micron filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2019-00123 |
| MDR Report Key | 8541375 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-04-23 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMILY ARNOULD |
| 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 | NDEHP SAPPHIRE MIC NV +1.2FLTR |
| Generic Name | ACCESSORIES, PUMP, INFUSION |
| Product Code | MRZ |
| Date Received | 2019-04-23 |
| Catalog Number | 163350402 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-04-23 |