MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A patient was treated in therapeutic plasma exchange (tpe), using a prismaflex tpe 2000 set and a prismaflex control unit.There was reportedly no issue during the priming of the set, but the customer noted a leakage from the effluent line of the set after treatment start.They reportedly noticed a hole in the line, causing the leakage.Treatment was discontinued and the extracorporeal blood circuit was returned to the patient.No medical intervention was needed due to the event.The event reportedly resulted in the loss of 100 ml of albumin for the patient.No additional information is available.

• 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 Key: 6571094
• MDR Text Key: 75412994
• Report Number: 8010182-2017-00032
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P830063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 107144
• Device Lot Number: 16H3001
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR