MAUDE Adverse Event Report: FRESENIUS MED CARE NORTH AMERICA FRESENIUS COMBISET BLOODLINES

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 01/30/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, dialysis started at 6:37 and was stopped at 8:00.Med records show that the pt's dialysis was stopped early because her blood pressure dropped and she became non responsive with her eyes open.Pt was administered saline and pt was able to talk and stated she was feeling okay.The needles were pulled and the pressure was held.The pt was discharged stable after refusing treatment to be restarted.The blood pressure at the time of this event was 151/80.Her pulse was 81.Blood pressure pre treatment was 149/92.Pulse was 96.

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.Based on 1925 pages of med records info, it appears that on (b)(6) 2013 the pt's blood pressure dropped and she became unresponsive during her dialysis treatment.Pt recovered but refused treatment to be resumed and was discharged.There is no documentation in the med record that shows a causal relationship between the pt's hemodialysis treatment and equipment and the pt's unresponsive episode.A supplemental report will be submitted upon completion of the plant's investigation.

• Brand Name: FRESENIUS COMBISET BLOODLINES
• Manufacturer (Section D): FRESENIUS MED CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: corie vazquez ; 920 winter st; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4548494
• MDR Text Key: 18000763
• Report Number: 8030665-2015-00092
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/30/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/25/2015
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: SALINE; FRESENIUS COMBISET BLOODLINES; NATURALYTE; FRESENIUS 2008K; VENOFER; GRANUFLO; FMC DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 66