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

Model Number 382400

Device Problems Device Alarm System (1012); Inaccurate Delivery (2339); Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

It was reported to covidien on 10/29/2014 that a customer had an issue with a feeding pump.The customer reports the pump has a bad valve selector that just spins in circles rather than selecting the flush or feed line.There is no alarm when this occurs and the pump continues to operate.After the set amount of fluid is delivered on a feed only setting, the pump tells the user that it delivered the correct amount.The volume the pump delivers is correct.The problem is when you measure the output from the feed and flush separately you will find that even though the pump was set to feed, if the valve is bad, it delivers almost exactly half the volume from the feed and the flush without ever alerting the user that there is an issue.Upon further clarification from the covidien, lead clinical product assurance analyst, the reported incident is more clearly described as, the customer notes that when the enteral pump is programmed to deliver a specific volume of enteral nutrition with a flush interval.The enteral volume displayed on the screen of the pump indicates that the programmed amount of enteral nutrition was delivered.The customer is finding that approximately half of the enteral nutrition and flush remain in the enteral feeding pump set.The customer attributes this issue to a bad pump valve selector.No patient involvement as issue identified during product testing within customer's biomedical engineering department.

Manufacturer Narrative

Submit date: 11/04/2014.An investigation is currently underway, upon completion, the results will be forwarded.Although the cited product (epump) has yet to be received from the customer, it is noted that this customer has filed (b)(4) additional similar events since (b)(4) 2014.An investigation of the noted epumps (twelve) was completed by the manufacture upon observational review and performance functional testing.Based upon the observations made during this evaluation, ten of the twelve pumps exhibited rotation of the valve stem shaft while the epump is in the feeding mode.This is a result of the valve stem shaft seizing up and forcing the valve stem shaft to rotate when it should remain stationary.As the valve is continuously passed by the feed and flush tubes of the feeding set, fluid is delivered from both the feed and flush components of the epump bag during the feeding and flushing modes.The total volume of fluid actually delivered will be approximately half feed and half flush.The epump will not alarm as the pump sensor continues to see fluid in the pump¿s tubing.While there were no obvious signs of ingress inside the epump gearboxes themselves, the affected pumps show various level of liquid ingress inside the pump housing and near the valve stem shaft of the ultrasound housing.In addition some of the gearboxes were found to have insufficient amounts of grease applied to the inside of the gearboxes.Liquid ingress is suspected as the root cause of the corrosion, whether from formula, water, or disinfecting chemicals.The insufficient amounts of grease found in some of the gearboxes may be a secondary contributing factor in the degradation of the gearboxes.The cited epumps were manufactured in 2007, 2011, 2012 and 2013.This cited epump for this event was manufactured in 2013.Some of the pcba boards of the returned epumps had mismatched pcbas serial numbers which indicates these pumps were repaired outside of covidien service channels.The servic.

Manufacturer Narrative

The device history record (dhr) review of the reported serial number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.One kangaroo epump was returned to the service department with a specific request for service/repair.Initial testing of the unit found that the stopcock turns in reverse while the rotor shaft spins; identifying a failure with the unit.The pump was escalated to a senior technician who found spill damage to the printed circuit board assembly (pcba) and gearbox causing the valve selectors to just spin in circles rather than selecting the flush or feed line and under delivery.The pump was sent to covidien r+d for further investigation.A corrective action has been taken to update the pump software.The new software version will alert the user when the error occurs.The product kangaroo epump was manufactured in 2013.A review of the service history records indicates there is no other service history recorded for this system.This information will be utilized for trending purposes to determine the need for corrective action.

Manufacturer Narrative

The emdr was submitted on (b)(6) 2014 however the below information did not completely populate.The additional narrative is being re-sent and will be continued.Although the cited product (epump) has yet to be received from the customer, it is noted that this customer has filed 12 additional similar events since (b)(6) 2014.An investigation of the noted epumps (twelve) was completed by the manufacture upon observational review and performance functional testing.Based upon the observations made during this evaluation, ten of the twelve pumps exhibited rotation of the valve stem shaft while the epump is in the feeding mode.This is a result of the valve stem shaft seizing up and forcing the valve stem shaft to rotate when it should remain stationary.As the valve is continuously passed by the feed and flush tubes of the feeding set, fluid is delivered from both the feed and flush components of the epump bag during the feeding and flushing modes.The total volume of fluid actually delivered will be approximately half feed and half flush.The epump will not alarm as the pump sensor continues to see fluid in the pump¿s tubing.While there were no obvious signs of ingress inside the epump gearboxes themselves, the affected pumps show various level of liquid ingress inside the pump housing and near the valve stem shaft of the ultrasound housing.In addition some of the gearboxes were found to have insufficient amounts of grease applied to the inside of the gearboxes.Liquid ingress is suspected as the root cause of the corrosion, whether from formula, water, or disinfecting chemicals.The insufficient amounts of grease found in some of the gearboxes may be a secondary contributing factor in the degradation of the gearboxes.

Event Description

The cited epumps were manufactured in 2007, 2011, 2012 and 2013.This cited epump for this event was manufactured in 2013.Some of the pcba boards of the returned epumps had mismatched pcbas serial numbers which indicates these pumps were repaired outside of covidien service channels.The service records for these epumps were not reported to the manufacture.Per the instruction for use manual, the epump must be periodically tested to assure proper functioning and safety.The recommended service interval is at least once per year.Cleaning should be performed as needed.Care must be taken to prevent liquid from entering the pump to avoid electric shock hazard, fire hazard, or damage to electrical component.If any of the following events occur, do not use the pump until it has been properly cleaned and serviced by personal trained in servicing kangaroo epump enteral feed and flush pump: setting of the pumpa/c power adapter or leakage into the pump interior during cleaning.pillage of large amounts of formula onto the pump exterior, or any spillage onto the a/c power adapter.

• 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 ; 5084524811
• MDR Report Key: 4256130
• MDR Text Key: 5104379
• Report Number: 3009247326-2014-00026
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Device Lot Number: C13048205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• 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