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

Catalog Number J2C1711

Device Problem Chemical Spillage (2894)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was manufactured november 18, 2013 ¿ november 19, 2013.The used device was received for evaluation.An initial visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional leak test was performed by filling the device with dyed water.While filling, backflow was visually observed at the fill port.Further visual inspection revealed that there was a particle approximately 1.2 mm in size, trapped under the check band.Spectrophotometric analysis revealed that the particle was made of acrylic.The leak from the fill port was determined to be caused by the trapped particle.The cause or origin of the particle under the check band was not determined.A capa has been opened to investigate trapped particulate matter causing backflow in infusors.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that drug solution came out of the fill port of a small volume infusor during filling.The reporter stated that they were not using a filter, and the bladder did not appear to be damaged.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received for evaluation.Upon completion of the device evaluation, or if any additional relevant information is received, a supplemental report will be submitted.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• 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: 3805570
• MDR Text Key: 11911053
• Report Number: 1416980-2014-15242
• Device Sequence Number: 1
• Product Code: MEB
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: J2C1711
• Device Lot Number: 13M069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 05/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2014
• 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