MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2016-08-02 for LEVEL 1? BLOOD-FLUID ADMINISTRATION SET D-300 manufactured by Smiths Medical Asd Inc..
[51001668]
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
[51001669]
The customer reported that when they opened the box of level 1 fast flow fluid warmer accessories infusion set , the tubing was found in multiple pieces. Since the customer thought the infusion set was supposed to be all in one piece it delayed rapid transfusion by almost five minutes for a patient actively losing blood (exsanguinating), who ultimately "expired" that same day. Response from the nurse noted that the delay in the patient's blood transfusion probably did not cause or contribute the patient's death due to the fact the patient had a tracheal - innominate fistula. The patient was exsanguinating and the fistula could not be repaired. No other infusion sets were used after the reported incident occurred. The box was not previously opened nor was there any damage to the box..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183502-2016-01654 |
| MDR Report Key | 5841756 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2016-08-02 |
| Date of Report | 2016-07-07 |
| Date of Event | 2016-07-06 |
| Date Mfgr Received | 2016-07-07 |
| Device Manufacturer Date | 2016-01-28 |
| Date Added to Maude | 2016-08-02 |
| 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 RD |
| 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 PARQUE INDUSTRIAL INTERNACIONA |
| Manufacturer City | TIJUANA 55425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 55425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1? BLOOD-FLUID ADMINISTRATION SET |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2016-08-02 |
| Catalog Number | D-300 |
| Lot Number | 3116852 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD INC. |
| Manufacturer Address | 1265 GREY FOX ROAD ST. PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-02 |