MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2016-03-15 for BAG SET, 500ML, ENTERALITE INF0500 manufactured by Moog Medical Devices Group.
[40390370]
The complainant returned the device for evaluation to moog medical devices group (mmdg) in utah. Mmdg sent the device via fedex to moog medical devices group, srl in costa rica. During transit the devices were inadvertently lost.
Patient Sequence No: 1, Text Type: N, H10
[40390371]
Customer states: care giver states the inf0500 sets with lot # cf1401704 are pumping air and not letting formula go through but air only, pump does not alarm. Care giver will change the set and the feeding will be completed without problems. Three pumps have been exchanged and all three have passed the rapid check procedure test, sn (b)(4), this last pump was tested and passed test before it was given to the patient. Customer would like an investigation as believed to be users error because pumps pass all testing without problems. Pumps are now with other patients after passing all testing and the pumps are working with no problems at all. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2016-00367 |
| MDR Report Key | 5503118 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2014-07-02 |
| Date Mfgr Received | 2014-08-06 |
| Device Manufacturer Date | 2015-07-03 |
| Date Added to Maude | 2016-03-15 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MATT BRINKERHOFF |
| Manufacturer Street | 4314 ZEVEX PARK LANE |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012641001 |
| Manufacturer G1 | MOOG MEDICAL DEVICES GROUP, SRL |
| Manufacturer Street | COYOL FREE ZONE AND BUSINESS PARK |
| Manufacturer City | ALAJUELA, SAN JOSE 20113 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 20113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAG SET, 500ML, ENTERALITE |
| Generic Name | ENTERAL FEEDING SET |
| Product Code | PIO |
| Date Received | 2016-03-15 |
| Model Number | INF0500 |
| Catalog Number | INF0500 |
| Lot Number | CF1401704 |
| Device Expiration Date | 2014-01-17 |
| Operator | OTHER CAREGIVERS |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOOG MEDICAL DEVICES GROUP |
| Manufacturer Address | 4314 ZEVEX PARK LANE SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-15 |