MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Catalog Number 115315

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A patient was receiving therapeutic plasma exchange (tpe) using a prismaflex tpe2000 set ckt and a prismaflex control unit.There was reportedly no issue during the priming of the set.One hour into treatment, the customer noticed that blood was leaking from the prismaflex tpe2000 set ckt, at the level of the connection of the access line to the blood pump segment.The tubing was reported to be slightly torn at this level.There was reportedly no alarm generated by the prismaflex machine.Due to this event, the treatment was stopped and then restarted using a new prismaflex tpe2000 set ckt.Reportedly, this external blood leakage caused a blood loss of 1 to 2 ml.There was reportedly no injury nor medical intervention related to this event.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: 6530060
• MDR Text Key: 74164510
• Report Number: 8010182-2017-00024
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: 115315
• Device Lot Number: 16C3103A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE (SN: UNKNOWN)
• Patient Outcome(s): Other