MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-08 for LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET UNK manufactured by Smiths Medical Asd, Inc..
[6014498]
A report was received explaining that the listed disposable was being used with an infusion device for rapid delivery on a paediatric patient in the operating room, when resistance was felt on the syringe when pulling fluid through the device. The disposable was reportedly kinking resulting in a low flow rate. The device had to be removed and un-warmed blood had to be administered.
Patient Sequence No: 1, Text Type: D, B5
[14204081]
Mfr. Completed the entire form. Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2015-00496 |
| MDR Report Key | 4913018 |
| Report Source | 06 |
| Date Received | 2015-07-08 |
| Date of Report | 2015-07-07 |
| Date Mfgr Received | 2015-06-17 |
| Date Added to Maude | 2015-07-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE SELIGA |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET |
| Generic Name | KLZ-BLOOD AND PLASMA WARMING DEVICE |
| Product Code | KZL |
| Date Received | 2015-07-08 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | ROCKLAND MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-07-08 |