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

Catalog Number 2C2118K

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the ¿top part of the blue lid¿ of a small volume intermate ¿came off during the picking stage¿.It was further stated ¿the unit was not injected with any drug and was segregated for quality investigation¿.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : the device was manufactured from july 30, 2019 - july 31, 2019.The device was received for evaluation.A visual inspection was performed, and it was noted that there was objective evidence that indicated the customer had injected/filled the sample with fluid because the bladder was found ruptured.The sample was returned for evaluation containing no fluid because the blue coil cap had been removed/detached by the customer to empty the fluid out of the housing because the bladder was ruptured.When the bladder ruptured, all fluid contained inside the bladder would empty inside the housing and in order to empty the fluid out of the housing, the blue coil cap must be manually removed or detached from the housing.The ruptured bladder was microscopically examined for signs of abnormality that may have potentially caused the rupture problem with no issues noted.The reported condition was verified.The cause of the reported condition could not be determined.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: INTERMATE
• Type of Device: PUMP, INFUSION
• 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: 9594049
• MDR Text Key: 175222107
• Report Number: 1416980-2019-07582
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412487939
• UDI-Public: (01)00085412487939
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2118K
• Device Lot Number: 19G060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2020
• 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