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

Catalog Number 2C2008K

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The lot 19e007 was manufactured between may 2-6, 2019.The device was received for evaluation.A visual inspection was performed, and it was noted that white striated marks resembling "crystals" were observed on the exterior surface of the bladder.The white striated marks were determined to be blooming antioxidant/ethanox which is a raw material/component of the bladder and not particulate or foreign matter.The purpose of antioxidant/ethanox is to prevent degradation of the bladder material.Blooming antioxidant/ethanox is a cosmetic condition and does not affect the functionality nor safety of the product.An ftir spectroscopy test was performed on the white striated marks and confirmed them to be ethanox/antioxidant.Functional testing was also performed, with no issues noted.The reported condition was not 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.

Event Description

It was reported that crystalized medication was observed on the surface of the balloon of a large volume infusor.Upon opening the plastic bag which contained the device, it was observed that some medication had leaked and crystalized within the device.This issue was discovered prior to patient use.There was no patient involvement.No additional information is available.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9526033
• MDR Text Key: 172905394
• Report Number: 1416980-2019-07174
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579382
• UDI-Public: (01)00085412579382
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 2C2008K
• Device Lot Number: 19E007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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