MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-07-21 for LEVEL 1 ? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS DI-50 manufactured by Smiths Healthcare Mfg.
[50099235]
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 of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[50099236]
User facility reported that the device was in use with patient (time in use not provided). According to reporter, air was seen in the line and patient sustained a lung embolism. Additional information has been requested regarding patient treatment. No permanent adverse effects have been reported.
Patient Sequence No: 1, Text Type: D, B5
[75463566]
One used level 1? Disposable normothermic iv administration set was returned for investigation. The sample was received inside a plastic bag and without its original packaging. Visual inspection was performed at distance of 12" to 24" and under normal conditions of illumination. Examination found no damage with the sample. During functional testing, the sample was connected to a level 1? H-1200 fast flow fluid warmer. After 5 minutes, which is the time required to empty a 1500ml fluid supply bag, the assembly showed no occlusions or air bubbles within the fluid path and the filter gas vent assembly was noted to be properly eliminating the bubbles from the system. The manufacturing facility performed a review of the manufacturing process. The review showed that assembly process was being performed as per procedures: this included review of basic assembly, pressure testing, and a review of the cap, vent with membrane that was being used during the manufacturing process. The manufacturing facility also performed an in-process visual inspection of (b)(4) products that were in the assembly area: the inspection showed no product damage or discrepancies that could result in air in the line. Investigation was unable to confirm the reported issue and found that the sample operated as intended. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2016-01499 |
| MDR Report Key | 5812080 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-21 |
| Date of Report | 2017-05-17 |
| Date of Event | 2016-04-22 |
| Date Mfgr Received | 2017-05-08 |
| Device Manufacturer Date | 2016-03-15 |
| Date Added to Maude | 2016-07-21 |
| 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 | LISA PERZ |
| Manufacturer Street | 1265 GREY FOX ROAD |
| Manufacturer City | ST PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS HEALTHCARE MFG |
| Manufacturer Street | S.A. DE C.V. AVE CALIDAD NO. 4 |
| Manufacturer City | TIJUANA, 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1 ? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2016-07-21 |
| Returned To Mfg | 2016-07-18 |
| Catalog Number | DI-50 |
| Lot Number | 3151168 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS HEALTHCARE MFG |
| Manufacturer Address | S.A. DE C.V. AVE CALIDAD NO. 4 TIJUANA, 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-21 |