MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO JOEY,PUMP W/POLE CLMP; JOEY PUMP

Model Number 383400

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Vomiting (2144); Weight Changes (2607)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, an updated investigation will be provided.

Event Description

It was reported to covidien on (b)(6) 2015 the sales rep told the customer to use the unit with a joey bag because he had been using an epump bag on the joey pump originally and then he used a different pump.Patient injury: baby is vomiting and consequently is losing weight - patient lost 0.12 kg (2 % of his body weight) no medical intervention required.Customer puts 6 ounces of nutrition, he adds a supplement, he shakes it and pours it into the bag and it over delivers.

Manufacturer Narrative

(b)(4).An investigation of kangaroo joey pump for the reported condition was performed on 09/15/2015 by the technical center for the reported condition of; unit over delivers.The evaluation revealed that the pump performs within specification.Multiple accuracy tests were performed with a rate set to 125 ml/h and set amount to 61 ml.The unit delivered 62 ml; unit passed accuracy test.The unit passed all tests and was recertified.It should be noted that the customer was using the incorrect feeding bag (epump bag) with the joey pump.Kangaroo joey was manufactured in 2015.A review of the device history record shows this device was released meeting all manufacturing specifications.

• Brand Name: KANGAROO JOEY,PUMP W/POLE CLMP
• Type of Device: JOEY 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 02018 ; 5084524811
• MDR Report Key: 5085132
• MDR Text Key: 26363920
• Report Number: 1282497-2015-00047
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• 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: 12/30/2015
• 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