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TPLC
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Device
pump, infusion
Product Code
FRN
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
B.BRAUN MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
4
DEKA RESEARCH & DEVELOPMENT
SUBSTANTIALLY EQUIVALENT
1
EITAN MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
2
IVENIX, INC.
SUBSTANTIALLY EQUIVALENT
1
Q CORE MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
REPRO-MEDICAL SYSTEM, INC., DBA KORU MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
2
ZOLL MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
16587
16587
2019
15857
15857
2020
94219
94219
2021
199379
199379
2022
888084
888084
2023
26180
26180
Device Problems
MDRs with this Device Problem
Events in those MDRs
Crack
715915
715915
Corroded
146321
146321
Break
92461
92461
Display Difficult to Read
63003
63003
Failure to Read Input Signal
43498
43498
Device Sensing Problem
42349
42349
Contamination
25857
25857
Device Alarm System
25456
25456
No Apparent Adverse Event
20332
20332
Display or Visual Feedback Problem
17247
17247
Appropriate Term/Code Not Available
16171
16171
Physical Resistance/Sticking
13801
13801
Electrical /Electronic Property Problem
13516
13516
Battery Problem
13063
13063
Failure to Calibrate
12989
12989
Insufficient Information
12240
12240
Circuit Failure
11677
11677
No Display/Image
9112
9112
Premature Discharge of Battery
9016
9016
Computer Software Problem
8522
8522
Failure to Align
8427
8427
Excess Flow or Over-Infusion
7515
7515
Insufficient Flow or Under Infusion
7452
7452
False Alarm
7410
7410
Misassembled
7229
7229
Deformation Due to Compressive Stress
4979
4979
Communication or Transmission Problem
4929
4929
Mechanics Altered
4825
4825
Protective Measures Problem
4710
4710
Application Program Freezes, Becomes Nonfunctional
4164
4164
Naturally Worn
4147
4147
Peeled/Delaminated
3991
3991
Improper Flow or Infusion
3640
3640
Failure to Sense
3587
3587
Failure to Power Up
3452
3452
Device Displays Incorrect Message
3317
3317
Output Problem
3229
3229
Fluid/Blood Leak
2983
2983
Charging Problem
2957
2957
Inaccurate Delivery
2878
2878
Defective Alarm
2803
2803
Obstruction of Flow
2784
2784
Mechanical Problem
2695
2695
Infusion or Flow Problem
2375
2375
Adverse Event Without Identified Device or Use Problem
2280
2280
Audible Prompt/Feedback Problem
2246
2246
Calibration Problem
2195
2195
Positioning Problem
2039
2039
Loose or Intermittent Connection
1829
1829
Pumping Stopped
1816
1816
Application Program Problem
1326
1326
Filling Problem
1299
1299
Material Discolored
1264
1264
Volume Accuracy Problem
1051
1051
Degraded
1018
1018
No Audible Prompt/Feedback
1010
1010
Pressure Problem
1002
1002
Failure to Analyze Signal
919
919
Device Operates Differently Than Expected
873
873
Complete Loss of Power
798
798
Difficult or Delayed Activation
792
792
Failure to Cycle
768
768
Device Markings/Labelling Problem
751
751
Incorrect, Inadequate or Imprecise Result or Readings
715
715
Fracture
689
689
Inaccurate Flow Rate
670
670
Defective Component
644
644
Use of Device Problem
637
637
Connection Problem
632
632
Inaudible or Unclear Audible Prompt/Feedback
604
604
Unexpected Shutdown
604
604
Air/Gas in Device
600
600
Power Problem
568
568
Application Program Version or Upgrade Problem
556
556
No Audible Alarm
530
530
Air Leak
525
525
Leak/Splash
505
505
Misassembly During Maintenance/Repair
503
503
Component Misassembled
491
491
Failure to Deliver
481
481
Inaccurate Information
453
453
Free or Unrestricted Flow
430
430
Noise, Audible
401
401
Patient Device Interaction Problem
398
398
Material Rupture
379
379
Computer Operating System Problem
353
353
Missing Information
334
334
Failure to Infuse
326
326
Wireless Communication Problem
312
312
Improper or Incorrect Procedure or Method
310
310
Thermal Decomposition of Device
294
294
Defective Device
262
262
Device Difficult to Setup or Prepare
252
252
Nonstandard Device
233
233
Intermittent Loss of Power
213
213
Therapeutic or Diagnostic Output Failure
204
204
Material Fragmentation
198
198
Bent
182
182
Material Integrity Problem
180
180
Failure to Charge
177
177
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
647446
647446
No Clinical Signs, Symptoms or Conditions
441370
441370
No Patient Involvement
117654
117656
No Consequences Or Impact To Patient
17583
17593
Hyperglycemia
8258
8258
No Information
7561
7563
No Known Impact Or Consequence To Patient
4453
4453
Hypoglycemia
3838
3838
Low Blood Pressure/ Hypotension
728
728
Diabetic Ketoacidosis
605
605
Nausea
441
441
Death
367
368
Vomiting
320
320
High Blood Pressure/ Hypertension
221
221
Loss of consciousness
209
209
Dyspnea
189
189
Abdominal Pain
168
168
Headache
153
153
Pain
144
144
Blood Loss
143
143
Cardiac Arrest
142
142
Overdose
133
133
No Code Available
118
118
Fatigue
102
102
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
94
94
Bradycardia
90
90
Tachycardia
86
86
Therapeutic Response, Increased
80
80
Dizziness
72
72
Shaking/Tremors
65
65
Coma
57
57
Anxiety
56
56
Seizures
54
54
Confusion/ Disorientation
53
53
Oversedation
47
47
Discomfort
46
46
Underdose
46
46
Chest Pain
45
45
Therapeutic Response, Decreased
43
43
Polydipsia
43
43
Not Applicable
41
41
Low Oxygen Saturation
41
41
Diarrhea
41
41
Therapeutic Effects, Unexpected
33
33
Injury
32
32
Hypoxia
31
31
Lethargy
30
30
Patient Problem/Medical Problem
29
29
Cardiopulmonary Arrest
29
29
Arrhythmia
28
29
Weakness
27
27
Hemorrhage/Bleeding
27
27
Venipuncture
26
26
Premature Labor
26
26
Urethral Stenosis/Stricture
26
26
Unspecified Infection
25
25
Hot Flashes/Flushes
25
25
Coagulation Disorder
24
24
Skin Irritation
23
23
Respiratory Distress
23
24
Muscle Weakness
23
23
Complaint, Ill-Defined
22
22
Malaise
22
22
Missed Dose
22
22
Sweating
21
21
Itching Sensation
20
20
Burning Sensation
20
20
Rash
19
19
Blurred Vision
19
19
Increased Respiratory Rate
18
18
Bruise/Contusion
18
18
Swelling/ Edema
18
18
Erythema
18
18
Infiltration into Tissue
18
18
Fetal Distress
18
18
Awareness during Anaesthesia
17
17
Inadequate Pain Relief
16
16
Hypersensitivity/Allergic reaction
15
15
Diaphoresis
15
15
Distress
15
15
Decreased Respiratory Rate
15
15
Fever
14
14
Balance Problems
13
13
Apnea
13
13
Skin Discoloration
13
13
Swelling
13
13
Irritability
13
13
Urinary Frequency
12
12
Irritation
11
11
Respiratory Failure
11
11
Dehydration
11
11
Toxicity
11
11
Sedation
11
11
Extravasation
11
11
Electrolyte Imbalance
11
11
Convulsion/Seizure
10
10
Asystole
10
10
Syncope/Fainting
10
10
Skin Inflammation/ Irritation
10
10
Convulsion, Clonic
9
9
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
I
Jan-29-2022
2
Baxter Healthcare Corporation
I
Aug-11-2021
3
Baxter Healthcare Corporation
I
Aug-06-2021
4
Baxter Healthcare Corporation
II
Apr-23-2021
5
Baxter Healthcare Corporation
II
Feb-25-2021
6
Baxter Healthcare Corporation
II
Dec-23-2020
7
Baxter Healthcare Corporation
I
Oct-22-2020
8
Baxter Healthcare Corporation
II
May-02-2019
9
Baxter Healthcare Corporation
II
Jun-07-2018
10
Baxter Healthcare Corporation
II
May-04-2018
11
Baxter Healthcare Corporation
II
Mar-12-2018
12
Bayer Medical Care, Inc.
II
Jan-06-2023
13
BioMedical Equipment Service Co (BMES)
I
Aug-06-2021
14
CME America LLC
II
Oct-29-2020
15
CME America, LLC
II
Dec-03-2020
16
CME America, LLC
I
Mar-18-2020
17
CME America, LLC
I
Mar-11-2020
18
CareFusion 303, Inc.
II
Mar-01-2023
19
CareFusion 303, Inc.
I
Apr-01-2021
20
CareFusion 303, Inc.
I
Sep-12-2020
21
CareFusion 303, Inc.
I
Sep-04-2020
22
CareFusion 303, Inc.
I
Sep-04-2020
23
CareFusion 303, Inc.
II
Aug-19-2020
24
CareFusion 303, Inc.
I
Aug-06-2020
25
CareFusion 303, Inc.
I
Aug-06-2020
26
CareFusion 303, Inc.
I
Aug-06-2020
27
CareFusion 303, Inc.
I
Mar-05-2020
28
CareFusion 303, Inc.
I
Jul-16-2019
29
CareFusion 303, Inc.
II
Jan-08-2018
30
Fenwal Inc
I
Aug-12-2019
31
Fresenius Vial Sa
II
Nov-02-2018
32
ICU Medical Inc
II
Oct-22-2019
33
ICU Medical Inc
II
Oct-14-2019
34
InfuTronix LLC
II
Mar-29-2022
35
InfuTronix LLC
II
Jul-23-2019
36
Infusion Pump Repair
I
May-10-2021
37
Iradimed Corporation
II
Mar-30-2023
38
Pacific Medical Group Inc.
I
Apr-19-2021
39
Repro-Med Systems, Inc.
II
Jan-05-2018
40
STEP-HAR MEDICAL LLC
I
May-10-2021
41
Smiths Medical ASD Inc.
II
Nov-21-2022
42
Smiths Medical ASD Inc.
I
Jun-21-2022
43
Smiths Medical ASD Inc.
II
Feb-17-2022
44
Smiths Medical ASD Inc.
I
Oct-19-2021
45
Smiths Medical ASD Inc.
I
Aug-06-2020
46
Smiths Medical ASD Inc.
I
Dec-12-2019
47
Smiths Medical ASD Inc.
II
Aug-08-2018
48
Smiths Medical ASD Inc.
II
Mar-05-2018
49
Smiths Medical ASD Inc.
II
Jan-04-2018
50
Smiths Medical ASD Inc.
II
Jan-02-2018
51
Tenacore LLC
I
Apr-02-2021
52
The Biomed Guys
I
Jun-01-2021
53
Zevex Incorporated (dba MOOG Medical Devices Group)
II
Jul-23-2019
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