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

Catalog Number 2C1073KJP

Device Problem Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the inner balloon of a half day infusor had a nick.The reporter stated that they were concerned that the ¿integrity may be compromised.¿ this was identified before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The lot was manufactured from december 12, 2014 ¿ december 17, 2014.One unit was received for evaluation.The unit was returned to the plant containing approximately 25 ml of fluid in its reservoir.Visual inspection noted a thin spot approximately 1.59 mm in size located on surface of the inflated reservoir.Microscopic examination of the thin spot indicated that it was not cut.A functional flow test was subsequently performed.During the functional test, the unit was manually inflated with solution and after fill the unit was allowed to flow until the solution in the reservoir was emptied.As a result, no signs of leak or rupture were found on the reservoir after the solution was emptied.Therefore, the integrity of the reservoir was not compromised and the functionality of the device was not impacted.The reported condition could not be verified.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.

• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4913339
• MDR Text Key: 6025061
• Report Number: 1416980-2015-28831
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 2C1073KJP
• Device Lot Number: 14N009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2015
• 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
• Patient Sequence Number: 1