MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL

Model Number 383400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

The incident device has been requested but to date has not been received for evaluation.If the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the kangaroo joey enteral feeding pump showed that it infused 98ml instead of the programmed 66ml during patient use.The registered nurse visualized the settings prior to the feed as follows: volume to be fed 66ml at a feeding rate of 132ml/hour.The rn noted that the feeding bag was empty at the end of the feeding.Per the enteral sticker, the bag was noted to have 111ml in it.When the rn looked at the pump after noticing the bag was empty, the pump history showed that 98ml were fed instead of the programmed 66ml.The rn looked at the other settings and noticed that the feeding rate was 300ml/hour with a flush volume of 60ml, which is not nicu specific programing.The rn notified the medical team immediately ((b)(6) nnp and dr.(b)(6)) and was instructed to place the infant in the prone position and aspirate the additional 32ml per ogt that was overfed.There was no injury to the patient.Additional information provided on july 01, 2021 stated that the rn assumed that the full volume of 111ml, as noted on the bag label, was infused to the patient.The rn did not change the rate when she started the first feeding of her shift and does not know why the feeding rate was reading 300ml/hr.She turned the pump off after the event and turned it back on to check the settings and saw 300ml/hr with a flush of 60ml/hr.The patient was fed elecare 27cal for 30 minutes.The rn does not know if any alarms were activated during the entire feeding.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12160988
• MDR Text Key: 261896934
• Report Number: 1282497-2021-10492
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/13/2021
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1