MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO EPUMP - NEW; FEEDING PUMP

Model Number 382400

Device Problems Defective Alarm (1014); Failure to Deliver (2338); Device Displays Incorrect Message (2591); Malposition of Device (2616)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a feeding pump.The customer states that on (b)(6) 2015 at approximately 9:30pm, the patient was started on a bolus feed using the epump.A flow error alarm occurred and with troubleshooting, the clinician found that the stopcock on the patient peg tube was not in the open position to allow administration of the bolus feed.Although the root cause for the flow error alarm was identified, the clinician elected to exchange the pump and the pump set.The second pump was programmed to deliver 288cc bolus feeding with a 125 cc water flush.A total of three bolus doses were expected to be delivered using 900cc enteral formula that was placed in the epump enteral bag.It was acknowledged that the first bolus (288cc was delivered) but the 2nd and third bolus doses were not delivered as programmed.It was noted that the epump did not produce any pump alarms.On (b)(6) 2015 am, the patient's blood sugar was 29 milligrams per deciliter.The patient was administered d50 iv following physician's standing orders.No additional medical intervention.Administration of bolus enteral feeds have proceeded using a syringe via a peg tube with no reported difficulties.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

Initial inspection of the unit found that the pump was functioning properly but the gearbox turned in reverse and is noisy.The unit was escalated to a senior technician where it passed performance, all functional, accuracy and recertification testing therefore, this complaint cannot be confirmed.The gearbox will be replaced for noise.The pump will be repaired and returned to stock.Product kangaroo epump - new was manufactured in 2013.A review of the service history records indicates there is no other service histories recorded for this system.A device history record review of the reported serial number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer (Section G): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 4479797
• MDR Text Key: 15123115
• Report Number: 1282497-2015-00009
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Device Lot Number: C13043794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other