MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-01 for LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET DI-50 manufactured by Smiths Medical Asd, Inc..
[58843920]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58843921]
It was reported that during use on a patient, the device and related disposable tubing were only able to infuse approximately half of expected blood units required. A massive transfusion protocol was activated on a patient experiencing a massive hemorrhage. The staff attempted to use a 14 and 16 gauge cannula without success. A central line was also unsuccessful. Ultimately the hospital staff ended up squeezing the blood through to the patient manually. A total of 32 units of blood had been opened in the attempt to manually infuse blood into the patient. The procedure lasted 4 hours and 10 minutes. The patient was discharged to the intensive care unit (icu) following procedure and was in critical condition. The clinical nurse stated "that this event could be one of several factors leading to the patient's current condition, however, it is hard to conclude that the device was responsible. " see mfr: 3012307300-2016-00223.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2016-00224 |
| MDR Report Key | 6069364 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-01 |
| Date of Report | 2016-10-07 |
| Date of Event | 2016-10-07 |
| Date Mfgr Received | 2016-10-07 |
| Date Added to Maude | 2016-11-01 |
| 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 | MS. LISA PERZ |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS MEDICAL OAKDALE |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH SUITE 100 |
| Manufacturer City | OAKDALE MN 55128 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55128 |
| 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 | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2016-11-01 |
| Catalog Number | DI-50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2016-11-01 |