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

Catalog Number 2C1704P

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

It was reported that an infusors medication ¿migrated to the plastic container." this malfunction occurred during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).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.The sample was returned for evaluation.A visual inspection confirmed a leak; more specifically there was a rupture in the bladder of the device.The device was microscopically examined.There were markings observed on the exterior surface of the bladder near the rupture line.If additional relevant information is obtained, then a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).Lot number 13b018 was manufactured february 7, 2013 ¿ february 8, 2013.A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.The cause of the rupture could not be determined.If additional relevant information is obtained, then a follow-up mdr 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: 3717876
• MDR Text Key: 4250051
• Report Number: 1416980-2014-10621
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2014

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: Other
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: 2C1704P
• Device Lot Number: 13B018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2014
• Initial Date FDA Received: 04/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2013
• 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