MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP BAG SET, 1200ML, ENFITCONNECTOR; ENTERAL FEEDING SET

Model Number INF1200-A

Device Problems Failure to Sense (1559); Failure to Infuse (2340)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

The complainant did not return the device for evaluation.A dhr review was performed on lot#cf1518410 no defects were found and no ncrs were issued during the original build.

Event Description

The initial reporter stated: customer states: problem with bag set returning 1 ea.Lot #cf1518410" said the bag had a kink and there was a mess, while they were cleaning up they had placed a clamp on the tubing, afterwards they forgot to remove the clamp that was placed below the pump on the tubing.After restarting the pump it did not alarm no flow out and continued to run with no food being delivered.At first they thought it was the pump but they took the bag and placed it on another pump to test if it was bag or pump, the same thing occurred on 2nd pump.First pump sn (b)(4) second pump sn (b)(4).After changing bag they wanted to check pumps again so they clamped it above the pump on the tubing and the pumps alarmed no flow in or no food as expected.The reporter did not provide lot specific information.(b)(4).

• Brand Name: BAG SET, 1200ML, ENFITCONNECTOR
• Type of Device: ENTERAL FEEDING SET
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP, SRL; coyol free zone and; business park; alajuela, san jose 20113 ; CS 20113
• Manufacturer Contact: matt brinkerhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 5503115
• MDR Text Key: 40391054
• Report Number: 1722139-2016-00362
• Device Sequence Number: 1
• Product Code: PIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/03/2018
• Device Model Number: INF1200-A
• Device Catalogue Number: INF1200-A
• Device Lot Number: CF1518410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 45