MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/POLE CLMP; ENTERAL FEEDING PUMP

Model Number 383400

Device Problems Defective Alarm (1014); Loss of Power (1475); Self-Activation or Keying (1557)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 02/02/2017.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that an issue occurred with an enteral feeding pump.The customer states the unit is not alarming and turns off by itself.

Manufacturer Narrative

Submit date: 02/03/2017.

Event Description

It was reported to covidien on (b)(6) 2017 that an issue occurred with an enteral feeding pump.The customer states the unit is not alarming and turns off by itself.The customer stated that the pump runs at night and the patient is only suppose to get so much volume.Per the patient's mother, the pump did not alarm at completion of the feeding so the patient was feed too much.There was no visual alarm and no sound per the mom.No other patient harm reported.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of, ¿the pump did not alarm at completion of the feeding so the patient was feed too much.¿ the unit was triaged and the customer complaint was partially verified.The unit was powered on and the post tones were heard.The unit was loaded with a feed/ flush set and allowed to run for more than 24 hours at 400ml/hr.The unit did not turn off automatically.Afterwards, the vtbd was set to deliver a specific volume.The unit indicated the feeding complete by alarming.The unit was then tested for accuracy.The unit was allowed to run for more than 15 minutes to reach steady state at 130ml/hr.The unit loaded with a new feed/ flush set and the feed rate was set to be 130ml/hr.Then, using a calibrated measuring cylinder and a stopwatch, the volume delivered by the pump was measured after 30 minutes.The volume measured was 73 ml, which is outside the specified tolerance.A trend has been identified and a corrective and preventative action has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO JOEY,PUMP W/POLE CLMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6296671
• MDR Text Key: 66602806
• Report Number: 3006451981-2017-00141
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1