MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008, NO HEPARIN LINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2742-9

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 01/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) a supplemental report will be submitted upon final review of medical records (if received) by post market clinical staff and completion of the plant¿s investigation.

Event Description

An inpatient user facility reported that with about 45 minutes left remaining in hemodialysis treatment, a patient experienced 200cc of blood loss due to the transducer line becoming disconnected from the transducer.The patient reported feeling lightheaded, experienced a drop in blood pressure, and was administered 1000cc of saline.The patient discontinued treatment and was not set-up with new supplies.The user facility physician on site was notified of the incident, and after examination it was determined no further evaluation or intervention was needed.The patient was sent home.The sample was discarded.

Manufacturer Narrative

The complaint device was not returned for analysis; however, companion samples were made available to the manufacturer for physical evaluation.A visual examination was performed on the tubing set of one companion sample; no defects were identified.One companion sample was then tested using a 2008k hemodialysis machine for simulated use.The bloodline was able to be primed with no visible issues.During the simulated use test, fluid flowed through the lines without issue.There were no observations of a leak or air bubbles and no level variation of the venous or arterial drip chambers was visible to indicate that the transducer disconnected from the bloodline set.The device worked as intended with no noted abnormalities and no defects identified.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The investigation into the cause of the reported problem was not able to confirm the failure mode.The reported defect of arterial line disconnection was not confirmed.The evaluation of the companion sample confirmed that the devices functioned fully as designed and met specification.

• Brand Name: FRESENIUS COMBISET 2008, NO HEPARIN LINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa 88780 ; MX 88780
• Manufacturer (Section G): REYNOSA; erika de reynosa,s.a. de c.v.; mike allen 1331 parque; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5396958
• MDR Text Key: 37041349
• Report Number: 8030665-2016-00041
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 15PR01073
• Other Device ID Number: 00840861100309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2015
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 83