MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-16 for 3M? RANGER? PRESSURE INFUSOR 145 14500 manufactured by 3m Health Care.
[70154268]
No information other than sex of patient was provided. No date was provided as to when the event occurred. The reporter stated the event date was prior to (b)(6) 2017 but did not provide or specify actual date. No information was provided as to serial number of the pressure infusor that was used. The pressure infusor was not isolated after the event. The hospital has many infusors so it is not known which one was involved. No serial number was recorded. It is not possible to indicate the manufacturing date of the pressure infusor without s/n. The reporter did indicate air in the line and tried to remove air from the patient after event occurred. 3m health care performed a review of product manuals applicable to their pressure infusor. The following warnings are included on the manuals as stated below. 2013 manual: warning: never infuse fluids if air bubbles are present in the fluid lines, as air embolism may result. 2014 & 2016 manuals: warning: to reduce the risks associated with air embolism and incorrect routing of fluids: never infuse fluids if air bubbles are present in the fluid lines. End of report.
Patient Sequence No: 1, Text Type: N, H10
[70154269]
A hospital employee reported that an adult female patient had coronary artery bypass graft surgery on an unspecified date prior to (b)(6) 2017. The patient was given fresh frozen plasma and saline administer through a y-tubing (product not specified) connected to a 3m? Ranger? Standard flow blood/fluid disposable set which was being warmed by a 3m ranger? Blood/fluid warming unit. A 3m? Ranger? Pressure infusor was also being used at the time. The patient allegedly developed an air embolism and died. The hospital employee noted that they saw air in the tubing during infusion. The product labeling does include a warning not to infuse if air bubbles are present in the fluid lines. See h10 for full warning statement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00032 |
| MDR Report Key | 6411677 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-16 |
| Date of Report | 2017-02-17 |
| Date Mfgr Received | 2017-02-17 |
| Date Added to Maude | 2017-03-16 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDA JOHNSEN |
| Manufacturer Street | 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer G1 | 3M COMPANY EDEN PRAIRIE |
| Manufacturer Street | 10351 WEST 70TH STREET |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55344 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? RANGER? PRESSURE INFUSOR |
| Generic Name | PRESSURE INFUSOR |
| Product Code | KZD |
| Date Received | 2017-03-16 |
| Model Number | 145 |
| Catalog Number | 14500 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Death | 2017-03-16 |