MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number 107144

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Malaise (2359)

Event Date 08/18/2015

Event Type  Injury  

Event Description

A patient in (b)(6) who had been diagnosed with a transplant rejection underwent therapeutic plasma exchange (tpe) treatment.At the initiation of the tpe treatment, the patient complained of back pain, nausea and malaise.The tpe treatment was temporarily suspended and the patient was administered analgesics and antihistamines; the treatment was then continued and completed as intended.During the investigation of this event, the customer indicated the patient may have suffered from hemolysis but this was never confirmed.

• 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 Key: 5222275
• MDR Text Key: 31196287
• Report Number: 8010182-2015-00080
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial
• Report Date: 11/13/2015

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 Date: 11/30/2017
• Device Model Number: 107144
• Device Lot Number: 14K0601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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: 73 YR