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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

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GAMBRO INDUSTRIES PRISMAFLEX TPE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Event Date 04/05/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
A patient was treated with therapeutic plasma exchange (tpe), using a prismaflex tpe 2000 set and a prismaflex control unit for the first time.About 15 minutes after treatment start, once the first albumin bag had been infused, the patient reportedly became pale and felt unwell.The patient reportedly presented with a significant blood pressure drop to 70/50 mmhg, and their oxygen saturation was at 90% whereas they had no respiratory history.Treatment was discontinued and the patient received a bolus of 100 ml of isotonic saline solution, which led to an increase of blood pressure to 90/50 mmhg 10 minutes later.The physician suspected a hemolysis without back pain.No additional information is available.
 
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Brand Name
PRISMAFLEX TPE
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 Key6568360
MDR Text Key75209267
Report Number8010182-2017-00030
Device Sequence Number1
Product Code MDP
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P830063
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/01/2020
Device Model NumberN/A
Device Catalogue Number107144
Device Lot Number17A1806
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/21/2017
Initial Date FDA Received05/15/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient Weight72
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