MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device was not returned for analysis; however, a companion sample was made available to the manufacturer for physical evaluation.A visual examination of the returned companion sample found the arterial and venous lines to be acceptable.The venous and arterial patient end connectors were examined and no defects were identified; specifically, no collar or taper damage identified.In addition, all bonds for both the arterial and venous lines were closely inspected and found to be properly assembled; no separation was observed.The device was then tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, there were no observations of a disconnection or leak from the patient venous and arterial connectors to fistula and main line tubing.The twister was rotated two hours into the test, and no air bubbles occurred in the system.Additionally, no leaks, level variations of venous and arterial chambers, or any alarms were generated during the simulated use testing.The device worked as intended with no noted abnormalities and no defects were 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 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 lot passed all release criteria.The investigation into the cause of the reported problem was not able to confirm the failure mode.The evaluation of the companion samples confirmed that the devices functioned fully as designed and met specification.

Event Description

A user facility reported that an external blood leak occurred while a patient was undergoing a hemodialysis (hd) treatment.The blood leak was observed where the blue connector for the needle completely separated from the bloodline tubing.Follow-up information from the nurse determined that the nurse was examining the blood line connection, when the connection separated in her hands.Therefore, the machine did not alarm as the nurse had been present at the time of the event and stopped treatment manually.The patient's estimated blood loss (ebl) was noted as being approximately 100ml.The incident occurred within the first 15 minutes of the start of the treatment.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient was setup with new supplies on the same 2008t hemodialysis machine, and then the treatment was continued.The treatment was successfully completed with no further issues.The complaint device was discarded by the user facility; however, a companion sample is available to be returned to the manufacturer for evaluation.Although requested, the companion sample has not been received.

• Brand Name: CUSTOM COMBI SET
• 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: 5944670
• MDR Text Key: 54563271
• Report Number: 8030665-2016-00474
• 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: Health Professional
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 16DR01299
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2016
• 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 Age: 43 YR
• Patient Weight: 77