MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,foreign,user facility report with the FDA on 2015-07-10 for LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET DI-60HL manufactured by Smiths Medical Asd, Inc..
[17335190]
A report was received explaining that the listed disposable was being used with an infusion device for rapid delivery on a pt in the operating room, when the disposable was reportedly kinking resulting in a loss of flow rate. The set was continued for use successfully with application of a splint across the kink. No adverse effects to pt reported.
Patient Sequence No: 1, Text Type: D, B5
[17436260]
Customer has not yet returned the device to the manufacturer for device eval. When and if the device becomes available and is returned and evaluated the manufacturer will file a f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
[28585119]
Used sample was returned for evaluation. Visual inspection observed the 3 lumen tube to appear bent at the section of the union with the strain relief. Functional testing was performed to simulate use by connecting the set to a fluid warming machine h-1200 and irrigating water. Once the warm water started to flow through the unit the triple lumen tube started to kink and alarm on the air detector/clamp control panel sounded as water did not flow through the filter. The tube was then cut in order to observe further and it was discovered that alignment of the tube and manifold ribs was incorrect. Manufacturing process was reviewed and an audit of production floor conducted by manufacturing engineer and confirmed that all procedures are performed as required. In attempt to reproduce the reported failure mode, two samples were tested on the h-1200 with one having triple lumen tube aligned with the manifold ribs correctly and the second sample misaligned. The triple lumen that was aligned correctly did not kink during irrigation of water. In the triple lumen tube that had misalignment a kink was observed, similar to the complaint sample. Most probably root cause is that the manifold and triple lumen tube were misaligned due to a bad coiled tube that caused the tube to twist after assembly. A re-training on procedure and awareness of this event was performed by production supervisor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2015-00503 |
| MDR Report Key | 4912726 |
| Report Source | 01,06,FOREIGN,USER FACILITY |
| Date Received | 2015-07-10 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-06-18 |
| Date Added to Maude | 2015-07-20 |
| 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 |
| Product Code | KZL |
| Date Received | 2015-07-10 |
| Model Number | NA |
| Catalog Number | DI-60HL |
| 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 | 2015-07-10 |