Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERMATE; PUMP, INFUSION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION INTERMATE; PUMP, INFUSION Back to Search Results
Catalog Number 2C2117K
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2023
Event Type  malfunction  
Event Description
It was reported that there was no fluid flow through a small volume intermate.The intermate was not infusing at all.The device was filled with ceftriaxone 2000mg in 50ml sodium chloride.This issue was observed during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Potential lot #: 22c025 and 22c017.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Correction made to e1: initial reporter first name: (b)(6) (previously submitted as ni).Correction made to e1: initial reporter last name: (b)(6) (previously submitted as ni).Correction made to e1: initial reporter address: (b)(6) road (previously submitted as ni).Correction made to e1: initial reporter city: (b)(6) (previously submitted as ni).Correction made to e1: initial reporter phone no.: (b)(6) (previously submitted as ni).E1: initial reporter postal code - (b)(6).H4: the suspected lot # 22c025 was manufactured on march 16, 2022.H4: the suspected lot # 22c017 was manufactured on march 11, 2022.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of these lots.The device was discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key16404703
MDR Text Key310072506
Report Number1416980-2023-00558
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C2117K
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received03/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CEFTRIAXONE..; SODIUM CHLORIDE.
Patient Age39 YR
Patient SexMale
-
-