MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMA TPE SET; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

Model Number PRISMAFLEX TPE1000

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 05/30/2016

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.

• Brand Name: PRISMA TPE SET
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
• 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 Key: 5800205
• MDR Text Key: 50629565
• Report Number: 8010182-2016-00060
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P830063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• 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 Received: 07/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: PRISMAFLEX TPE1000
• Device Catalogue Number: 107143
• Device Lot Number: 14G0206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2016
• 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 Number: Z-2203-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 MO
• Patient Weight: 11