MAUDE Adverse Event Report: COVIDIEN; PUMP, INFUSION, ENTERAL

Device Problem Air/Gas in Device (4062)

Patient Problems Vomiting (2144); Abdominal Distention (2601); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

The initial reporter was unable to provide the product number or the lot number.Due to this, the unique identifier (udi) is not available.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that in 2017 her daughter began using a feeding pump after a surgery she had.She was unable to eat on her own for a little bit so they started her on this feeding tube/pump.As soon as she started the feeding pump, she began puking, had trouble gaining weight, and had abdominal distention.She was never able to drink a bottle and on her own again.On (b)(6) 2017 they woke up in the morning and her daughter had passed away in her sleep.The customer stated they thought this was due to her health problems she had.She also had several medications she took and they inserted through the feeding tube, as directed by her heart doctor.Additional information received from the initial reporter stated that her daughter had open heart surgery prior to requiring the feeding pump.She was started on the feeding pump in (b)(6) 2017.She had to get blood transfusions frequently and had pulmonary hypertension and asd (heart issue).The initial reporter stated unknown when asked what the medical team identified as the cause of the her daughter's symptoms (puking, trouble gaining weight, abdominal distention).She also stated that she does not remember the medicine she was taking and does not have access to the medical charts.The cause of death was determined to be natural causes.The feeding pump model and serial number are unknown.She was using a ng tube.The product code and lot number of the feeding tube are unknown.The feeding set type, product number and lot number are unknown.The customer stated it is unknown if there were any issues with any of the devices.Further information provided by the initial reporter stated that she recently asked the pediatrician who took care of her daughter if she thought that the feeding pump malfunction had anything to do with her daughter's weight gain issues.The pediatrician responded stating they do not think that the pump influenced the problems.They had to work pretty hard to get her to gain weight and her stroke happened after her heart surgery; they agree that it may have played a role with her feeding issues (coordination of sucking and swallowing, significant gag) but her heart having to work harder due to her pulmonary hypertension also caused fluid to back into her lungs which may have also caused some of her vomiting and feeding issues (and she would need to be transfused which would also cause fluid issues).On march 1, 2021 cardinal health sent out a medical device correction letter regarding the kangaroo enteral feed pumping sets.The purpose of this communication was to advise customers of the potential for air appearing in the enteral feed pumping set tubing during set-up.Although there was limited information provided by the customer regarding the specific issue relating to the pump / pump set, this complaint will be filed as the reportable malfunction of air in the line with a pump set since it was in response to the communication sent out to customers regarding this issue with the kangaroo enteral feeding pump sets.

• 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 ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11749500
• MDR Text Key: 248199532
• Report Number: 1282497-2021-10135
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Type of Device Usage: N
• Patient Sequence Number: 1