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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 PRISMAFLEX TPE 1000
Device Problem Break (1069)
Patient Problem Blood Loss (2597)
Event Date 05/31/2016
Event Type  malfunction  
Event Description
A pediatric patient in (b)(6) was undergoing therapeutic plasma exchange treatment (tpe) for guillain-barre syndrome.The tpe set was connected via an extracorporeal membrane oxygenation (ecmo) circuit with smith stopcocks.At the completion of the tpe treatment, kelly clamps were used to disconnect the tpe access line from the ecmo circuit and the male luer broke off in the stopcock.The blood in the extracorporeal circuit was not returned to the patient resulting in an estimated blood loss of 71 ml.
 
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Brand Name
PRISMAFLEX TPE
Manufacturer (Section D)
GAMBRO INDUSTRIES
7 avenue lionel terray
meyzieu 69883
FR  69883
Manufacturer Contact
thierry palkovics
7 avenue lionel terray
meyzieu 
FR  
472452525
MDR Report Key5800206
MDR Text Key50636223
Report Number8010182-2016-00059
Device Sequence Number1
Product Code MDP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P830063
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Remedial Action Recall
Type of Report Initial
Report Date 07/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRISMAFLEX TPE 1000
Device Catalogue Number107143
Device Lot Number14G0206
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/18/2016
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
Removal/Correction NumberZ-2203-2014
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 MO
Patient Weight11
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