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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX HF1400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO INDUSTRIES PRISMAFLEX HF1400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number N/A
Device Problems Break (1069); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2017
Event Type  malfunction  
Event Description
It was reported that the ¿connection tubing¿ of a prismaflex hf1400 set was broken. It was not specified when in the process this occurred. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NamePRISMAFLEX HF1400
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO INDUSTRIES
7 avenue lionel terray
meyzieu 69883
FR 69883
Manufacturer (Section G)
GAMBRO INDUSTRIES
7 avenue lionel terray
meyzieu
FR
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6755176
MDR Text Key81486407
Report Number8010182-2017-00053
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number107142
Device Lot NumberASKU
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/31/2017
Distributor Facility Aware Date07/05/2017
Event Location Hospital
Date Report to Manufacturer07/31/2017
Date Manufacturer Received07/05/2017
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 Treatment Data
Date Received: 07/31/2017 Patient Sequence Number: 1
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