MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE; PUMP, INFUSION, PCA

Catalog Number J2C1067

Device Problems Air Leak (1008); Improper Flow or Infusion (2954)

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

Event Date 02/20/2014

Event Type  malfunction  

Event Description

It was reported that a patient control module (pcm) was not functioning properly.The reporter stated that after connecting the pcm to a filled infusor (drug solution unknown) and removing the shipping tab from the medication demand button in order to perform priming, drug solution flowed freely out of the patient line.Furthermore, when the pcm was raise to a higher level than the infusor, it was noticed that the solution flowed backward to the pcm line connection.This was indicated by a downward movement of air bubbles which were present inside of the tubing.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The patient control module (pcm) device was returned for evaluation; however the infusor mentioned in the initial report was not returned.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional test was subsequently performed by connecting the pcm unit to a testing infusor unit.During the functional test, flow was observed at the patient line/basal luer.This is normal because the flow is coming from the connected infusor and therefore is not a defect.When the pcm unit was raised higher than the connected infusor unit, no evidence of fluid backflow to the pcm line was observed.The pcm's actuator was found to be functioning properly.The average dispensed volume was found to be within the specification of the product.The initial evaluation did not confirm the reported condition.A batch review will be performed.  if any relevant information is obtained that is related to the reported event, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The lot 13j007 was manufactured between september 11, 2013 and september 19, 2013.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The sample evaluation concluded that the device performed within product specification.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue, bldg 3; irvine CA 92614
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue, bldg 3; irvine CA 92614
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3686387
• MDR Text Key: 4302207
• Report Number: 1416980-2014-08975
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: J2C1067
• Device Lot Number: 13J007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1