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TPLC
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Device
pump, infusion, elastomeric
Product Code
MEB
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACE MEDICAL US, LLC
SUBSTANTIALLY EQUIVALENT
1
EPIC MEDICAL PTE LTD
SUBSTANTIALLY EQUIVALENT
1
HALYARD HEALTH
SUBSTANTIALLY EQUIVALENT
1
I-FLOW LLC
SUBSTANTIALLY EQUIVALENT
1
MFS - MEDICAL FLOW SYSTEMS LTD
SUBSTANTIALLY EQUIVALENT
1
1. K131247
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
MDR Year
MDR Reports
MDR Events
2014
2695
2695
2015
2979
2979
2016
2146
2146
2017
1653
1653
2018
1473
1564
2019
974
4421
2020
2731
3223
2021
1802
1802
2022
1288
1288
2023
1249
1249
2024
430
430
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
4342
7058
Filling Problem
3776
4288
Material Rupture
1938
2259
No Flow
1871
2146
Device Contamination with Chemical or Other Material
1747
1896
Infusion or Flow Problem
1056
1056
Excess Flow or Over-Infusion
966
966
Leak/Splash
635
635
Inaccurate Flow Rate
632
632
Failure to Infuse
461
461
Break
403
425
Adverse Event Without Identified Device or Use Problem
267
267
Disconnection
258
258
Insufficient Flow or Under Infusion
243
243
Failure to Deliver
146
146
Device Operates Differently Than Expected
143
143
Detachment Of Device Component
142
142
Component Missing
135
138
Crack
95
99
Improper Flow or Infusion
89
89
Loose or Intermittent Connection
87
88
Contamination /Decontamination Problem
45
45
Failure to Prime
44
44
Material Separation
40
40
Detachment of Device or Device Component
39
40
Material Deformation
35
36
Reflux within Device
34
34
Improper or Incorrect Procedure or Method
32
32
Burst Container or Vessel
29
29
Particulates
25
25
Material Split, Cut or Torn
25
26
Backflow
19
19
Material Twisted/Bent
15
15
Insufficient Information
14
14
Physical Resistance/Sticking
14
14
Material Integrity Problem
13
13
Split
13
13
Defective Device
13
13
Material Puncture/Hole
12
15
Sticking
11
11
Deflation Problem
11
11
Connection Problem
11
11
Inaccurate Delivery
11
11
Pumping Problem
11
11
Scratched Material
11
11
Appropriate Term/Code Not Available
11
11
Chemical Spillage
10
10
Fracture
9
9
Product Quality Problem
9
9
Application Program Problem: Medication Error
9
9
Torn Material
8
8
Partial Blockage
8
8
Cut In Material
8
8
Defective Component
8
8
Obstruction of Flow
7
7
Device Contaminated During Manufacture or Shipping
7
7
Misconnection
7
7
Use of Device Problem
7
7
Device Damaged Prior to Use
6
6
Overfill
5
5
Patient-Device Incompatibility
5
5
Device Dislodged or Dislocated
5
5
Material Fragmentation
5
5
Hole In Material
5
5
Air/Gas in Device
5
5
Mechanical Problem
4
4
Inadequate Instructions for Healthcare Professional
4
4
Device Alarm System
4
4
Bent
4
4
Stretched
4
4
Short Fill
4
4
Free or Unrestricted Flow
4
4
Device Markings/Labelling Problem
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Device Displays Incorrect Message
4
4
Malposition of Device
4
4
Device Operational Issue
3
3
Device Packaging Compromised
3
3
Difficult to Open or Close
3
3
Fitting Problem
3
26
Material Perforation
3
3
Therapeutic or Diagnostic Output Failure
3
3
Packaging Problem
3
3
Positioning Problem
3
3
Environmental Particulates
3
3
Volume Accuracy Problem
3
3
Device Slipped
3
3
Device Inoperable
3
3
Retraction Problem
3
3
Precipitate in Device or Device Ingredient
3
3
Device Difficult to Setup or Prepare
3
3
Failure to Pump
3
3
Degraded
3
3
Material Discolored
3
3
Melted
3
3
Priming Problem
3
3
Noise, Audible
3
3
Activation Problem
2
2
Migration or Expulsion of Device
2
2
Kinked
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
6982
9090
No Clinical Signs, Symptoms or Conditions
4203
4203
No Consequences Or Impact To Patient
4003
4879
No Known Impact Or Consequence To Patient
2547
3597
No Information
498
498
Insufficient Information
146
146
Pain
125
125
Underdose
113
113
Nausea
106
106
No Code Available
95
95
Overdose
80
80
Numbness
62
62
Reaction
45
45
Tinnitus
44
44
Vomiting
42
42
Unspecified Infection
41
41
Fatigue
38
38
Foreign Body In Patient
37
37
Toxicity
33
33
Chemical Exposure
31
31
Discomfort
30
30
Fever
30
30
Dizziness
29
29
Diarrhea
25
25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
25
25
Device Embedded In Tissue or Plaque
24
24
Malaise
24
24
Injury
20
20
Rash
20
20
Death
20
20
Tachycardia
19
19
Swelling
18
18
Chest Pain
17
17
Itching Sensation
17
17
Dyspnea
16
16
Abdominal Pain
15
15
Inadequate Pain Relief
15
15
Blurred Vision
14
14
High Blood Pressure/ Hypertension
14
14
Headache
13
13
Chills
13
13
Confusion/ Disorientation
13
13
Missed Dose
11
11
Hot Flashes/Flushes
11
11
Low Blood Pressure/ Hypotension
11
11
Muscle Weakness
10
10
Respiratory Distress
10
10
Post Operative Wound Infection
10
10
Anxiety
10
10
Lethargy
10
10
Taste Disorder
9
9
Seizures
9
9
Weakness
9
9
Inflammation
9
9
Nerve Damage
8
8
Shaking/Tremors
8
8
Palpitations
7
7
Dysphagia/ Odynophagia
7
7
Cardiac Arrest
7
7
Diaphoresis
7
7
Tingling
6
6
Bacterial Infection
6
6
Sweating
6
6
Thromboembolism
5
5
Swelling/ Edema
5
5
Pulmonary Embolism
5
5
Dehydration
5
5
Necrosis
5
5
Jaundice
5
5
Burning Sensation
5
5
Skin Irritation
5
5
Neuropathy
4
4
Ulcer
4
4
Hyperthermia
4
4
Edema
4
4
Sleep Dysfunction
4
4
Abdominal Cramps
3
3
Vascular System (Circulation), Impaired
3
3
Decreased Sensitivity
3
3
Patient Problem/Medical Problem
3
3
Partial thickness (Second Degree) Burn
3
3
Test Result
3
3
Unspecified Kidney or Urinary Problem
3
3
Erythema
3
3
Fall
3
3
Cellulitis
3
3
Purulent Discharge
3
3
Arrhythmia
3
3
Hematoma
3
3
Hemorrhage/Bleeding
3
3
Incontinence
3
3
Muscle Spasm(s)
3
3
Peeling
3
3
Pneumonia
3
3
Distress
3
3
Arthralgia
3
3
Complaint, Ill-Defined
3
3
Sprain
3
3
Skin Discoloration
3
3
Sepsis
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Feb-25-2019
2
B. Braun Medical, Inc.
II
Sep-16-2014
3
B. Braun Medical, Inc.
II
Feb-03-2014
4
Baxter Healthcare Corp.
II
Jul-10-2013
5
Baxter Healthcare Corp.
II
Jun-27-2013
6
Baxter Healthcare Corp.
II
Jun-27-2013
7
Baxter Healthcare Corp.
II
May-05-2011
8
First Medical Source LLC
I
Oct-30-2012
9
Hsmg, Inc. D/b/a Smartinfuser Usa
II
Apr-14-2011
10
Hsmg, Inc. D/b/a Smartinfuser Usa
II
Mar-08-2010
11
I-Flow Corporation
I
Aug-28-2012
12
I-Flow Corporation
II
Jul-28-2011
13
I-Flow Corporation
II
Sep-14-2009
14
Leventon S. A. U.
II
Aug-23-2019
15
Progressive Medical Inc
I
Oct-24-2011
16
Stryker Instruments Div. of Stryker Corporation
II
Sep-04-2009
17
Symbios Medical Products, LLC
I
Jun-06-2013
18
Symbios Medical Products, LLC
I
Mar-13-2013
19
Victus, Inc.
I
Oct-24-2011
20
Wolf Medical Supply Inc.
I
Nov-23-2011
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