MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number 03-2622-3

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a minor blood loss event occurred during a patient¿s hemodialysis (hd) treatment.A clamp was reportedly missing from the arterial transducer on a fresenius combi set bloodline.The missing clamp was not identified prior to utilization and resulted in arterial pressure alarms.After the staff recognized the combi set was missing a clamp, the treatment was discontinued.The patient¿s treatment was restarted with new supplies on the same machine.The staff reportedly returned the majority of the patient¿s blood, and blood loss was minimal.A specific volume of blood loss was not provided.It was reported that the blood loss occurred due to the bloodline being replaced with a new one.The machine, a fresenius 4008s, did not alarm with a blood leak alert.The patient was also using a fresenius dialyzer - an opitflux 180nre.Blood test strips were not used.The patient completed treatment after being re-setup with new supplies.It was confirmed that there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The combi set was not available to be returned for a manufacturer evaluation as it was reportedly discarded.

Manufacturer Narrative

Additional information: h4, the manufacturing date was inadvertently omitted from the previous report.Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, a photograph of the bloodline connected to the machine was provided by the customer.Upon review of the photograph, it was confirmed there was a missing clamp on the arterial side of the combi set.The arterial monitor line also appeared to be missing.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.The reported event was confirmed based on the provided photographs.

• Brand Name: COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 10176146
• MDR Text Key: 195807669
• Report Number: 8030665-2020-00842
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 19NR01278
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 4008S MACHINE; FRESENIUS OPTIFLUX 180NRE DIALYZER; FRESENIUS 4008S MACHINE; FRESENIUS OPTIFLUX 180NRE DIALYZER
• Patient Age: 78 YR
• Patient Weight: 46