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

Catalog Number 2C2111K

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume intermate had flow issue.This issue was further described as, ¿pump venting was not possible after addition of carrier solution¿.This was observed during preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured between july 07, 2021 to july 08, 2021.H10: the device was received for evaluation containing fluid in the bladder.Visual inspection on the unit via the naked eye was performed and no fluid was observed coming out of the tubing line after the slide clamp was disengaged and the blue winged luer cap was opened.After the tubing line was cut, no evidence of fluid was observed flowing out of the tubing line which indicated blockage at the junction of the tubing and stressmember located at the upper area of the device.The device was disassembled for further examination and the needle located inside the stressmember was found to be misassembled.The needle touched the tubing port which blocked the fluid path and did not allow fluid to flow out of the tubing line.The reported condition was verified.The cause of the condition was due to a manufacturing issue.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 ; 2242702068
• MDR Report Key: 14568180
• MDR Text Key: 293139431
• Report Number: 1416980-2022-02813
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412488103
• UDI-Public: (01)00085412488103
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2111K
• Device Lot Number: 21G013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2022
• 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: Initial
• Patient Sequence Number: 1