MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-18 for LS HEMA Y-TP BLD CLV 12434 manufactured by Hospira Costa Rica Ltd..
[22252323]
The customer contact reported that one of the tubes that lead from the spike to the drip chamber was loose, subsequently a leak was noted. It was reported that during priming, prior to pt use, fluid was found around the outside of the drip chamber, the bubbles occurring at the connection when drip chamber was squeezed. It was further reported, that when the tubing set was placed back in the packaging, one of the tubes that leads from the spike to the blood filter housing assembly came apart where it entered the blood filter housing assembly. There were no reported adverse pt events and no reported delay of therapy critical for the pt. No medical interventions were required. No add'l info was provided.
Patient Sequence No: 1, Text Type: D, B5
[22277557]
The device was rec'd. Investigation is not complete. This report represents all the info known by the reporter upon query by hospira personnel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615050-2015-01099 |
| MDR Report Key | 4787220 |
| Report Source | 05 |
| Date Received | 2015-05-18 |
| Date of Report | 2015-04-28 |
| Date of Event | 2015-03-01 |
| Date Mfgr Received | 2015-04-28 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-06-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUERGEN SCHMIDER, MD, VP |
| Manufacturer Street | 275 N FIELD DR BLDG NO H2-1EAST, DEPT NO 097U |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2242125740 |
| Manufacturer G1 | HOSPIRA COSTA RICA LTD. |
| Manufacturer Street | ZONA FRANCA GLOBAL |
| Manufacturer City | LA AURORA HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LS HEMA Y-TP BLD CLV |
| Generic Name | 80 FRA |
| Product Code | FRA |
| Date Received | 2015-05-18 |
| Returned To Mfg | 2015-05-13 |
| Model Number | NA |
| Catalog Number | 12434 |
| Lot Number | 441365H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-18 |