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 2015-08-11 for LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET DI-60HL manufactured by Smiths Medical Asd, Inc.,.
[23250077]
Smiths medical has received the sample device. A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site. Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
Patient Sequence No: 1, Text Type: N, H10
[23250078]
According to reporter, the device was being prepared prior to use with patient. The patient was already in hypovolemic shock. When the device luer was attached to the 3 way stopcock (brand name not provided), the fluid warming set luer became detached from the rest of the set. According to reporter, the patient required resuscitation during this time when an alternate set was prepared. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[29831991]
Seven photographs of the complaint product were provided by customer. These photographs showed the level 1 fluid warming set with a detached luer connector and an unattached stopcock (unknown manufacturer). Five samples were returned for evaluation: one of these devices was in used condition and retained the swivel return connector but was missing the luer connector. Examination of the used sample showed the measured dimensions of the swivel return connector were within specifications. Because the detached luer connector was not returned for this sample, no functional testing could be performed with this sample. The manufacturing facility performed an examination of the unused samples. The returned unused samples were all found to meet with specifications (tubing assemblies, swivel return connectors and luer connectors were all assembled as per specifications). Because only a portion of the used complaint device was returned; the root cause could not be definitely established. The manufacturing facility performed an audit of the manufacturing process for this device; this review showed no products with similar luer connector detachment or problems with the assembly process. This review determined that the assembly was being performed as per manufacturing procedure and the products produced were meeting with in-process inspection criteria. The inspection criteria include: visual inspection for voids, dents or cracks; separation force testing and torque verification testing. The investigation could not confirm the reported issue occurred due to an intrinsic device problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2015-00575 |
| MDR Report Key | 5008436 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-11 |
| Date of Report | 2015-08-10 |
| Date of Event | 2015-07-20 |
| Date Mfgr Received | 2015-07-29 |
| Device Manufacturer Date | 2014-10-30 |
| Date Added to Maude | 2015-08-17 |
| 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 | MICHELE SELIGA |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287604 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC., |
| Manufacturer Street | 160 WEYMOUTH ST. |
| Manufacturer City | ROCKLAND MA 02370 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02370 |
| 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 | KZL - BLOOD AND PLASMA WARMING DEVICE |
| Product Code | KZL |
| Date Received | 2015-08-11 |
| Returned To Mfg | 2015-07-03 |
| Model Number | NA |
| Catalog Number | DI-60HL |
| Lot Number | 2788536 |
| ID Number | NA |
| Device Expiration Date | 2018-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2015-08-11 |