MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBI SET 8MM PRE 2 VENOUS INJECT SITE

Catalog Number 03-2922-7

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

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

Event Date 08/05/2015

Event Type  No Answer Provided  

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.A supplemental report will be submitted upon completion of the investigation.

Event Description

Upon medical record review obtained for an unrelated event, it was learned the pt had an unresponsive episode during dialysis on (b)(6) 2015 and required cpr and hospitalization.Upon follow up with the pt care technician (pct) it was confirmed the morbidly obese end stage renal disease (esrd) pt with history of cardiac disease became unresponsive during hemodialysis, required cpr and was hospitalized.He returned to dialysis after the hospitalization.The pct does not have any product info at this time but stated there were no product malfunctions alleged or found.The machine was not evaluated but remains in service without issue.The dialyzer was discarded.From medical records-hemodialysis orders: treatment time- 3 hours 15 minutes, blood flow rate-400, dialysate flow rate-800, liters processed-102.0.Base sodium and bicarb were not given.Pre treatment weight: 149.0 kg.Blood pressure (bp) 118/64, pulse 83, temperature 98.1.Approximately 20 minutes into treatment the pt yells out "hello" and within seconds becomes unresponsive, pulse weak and thready, unable to obtain blood pressure.Respirations shallow and snoring.Placed on oxygen (02) non-rebreather at 15 liters per minute (lpm).Automated defibrillator advised no shock.Blood was returned and 110ml normal saline was given.Blood glucose 122.Pt diaphoretic.Post bp was 110/62, pulse 80, 02 saturation 90% on 10 lpm.Transported to hospital via ambulance.There was no documentation that cpr was performed.

Manufacturer Narrative

The clinical investigation revealed the following: the pt was evaluated at the hospital but not admitted.The pt has a history of atrial fibrillation as well as other cardiac issues.There is no info in the medical record that indicates there is a causal relationship between the pt's hemodialysis and concomitant products and the pt's unresponsive episode.The device was not returned to the manufacturer for physical evaluation.The customer was unable to provide the manufacturer with the lot number of the combiset used in the reported event.As no lot number was provided by the complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event.The batch production records for these lots were reviewed.The batch records confirmed that released product met specifications; and documented manufacturing process controls were within specification.Per the documented product investigation, there was no indication that the fresenius combiset caused, contributed to or was a factor in the reported event.

• Brand Name: COMBI SET 8MM PRE 2 VENOUS INJECT SITE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA ; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street ; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5180264
• MDR Text Key: 29417942
• Report Number: 8030665-2015-00483
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2922-7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 149