MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET 2008 6.35MM POST; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2631-4

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problems Loss of consciousness (2418); Blood Loss (2597)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodline products from the reported catalog number (03-2631-4) shipped to this account within the selected time frame.A records review was performed on all lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.

Event Description

A biomedical technician (bmt) from a hospital's hemodialysis unit reported an event of blood loss, which resulted in medical intervention and a prolonged hospital admission.Upon follow up with the unit's nurse, it was reported that towards the end of treatment, the venous line became disconnected from the patient's catheter access site, resulting in patient blood loss.The patient's estimated blood loss (ebl) was noted as being approximately 600ml.The machine did not alarm.The patient exhibited a decreased level of consciousness and did not respond when the nursing staff attempted to gain the patient's attention.At this time, 600ml of normal saline was administered.The patient came-to and reported a feeling of "wooziness" for approximately 1 minute, and then felt better.The patient's hemoglobin was sampled, and came back normal.The patient was set to be discharged on the day the event occurred, however, the decision was made to keep the patient overnight.The following day, the patient's hemoglobin was sampled again, this time reading 6.6.The patient was transfused with an unknown amount of blood, and then discharged from the hospital.The patient was re-admitted to the hospital 2 days later for an unknown reason.Although requested, no further information was made available.

• Brand Name: COMBISET 2008 6.35MM POST
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5997831
• MDR Text Key: 56401111
• Report Number: 8030665-2016-00524
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2631-4
• Other Device ID Number: 00840861100255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• 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): Hospitalization; Required Intervention