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

Catalog Number 03-2722-9

Device Problem Filling Problem (1233)

Patient Problem Blood Loss (2597)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility patient care technician (pct) reported during a hemodialysis (hd) treatment the arterial chamber was not filling with blood and the f160nr dialyzer was full of air.No leak was noted and the treatment had not yet been started.The patient did not require any medical intervention as a result of the reported issue.No defect or damage was observed to the dialyzer, bloodline or packaging.The patient completed treatment with a new set up, same machine.No issues were noted with priming.The estimated blood loss for the patient was 80ml.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.However, 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.

Event Description

A user facility patient care technician (pct) reported during a hemodialysis (hd) treatment the arterial chamber was not filling with blood and the f160nr dialyzer was full of air.No leak was noted and the treatment had not yet been started.The patient did not require any medical intervention as a result of the reported issue.No defect or damage was observed to the dialyzer, bloodline or packaging.The patient completed treatment with a new set up, same machine.No issues were noted with priming.The estimated blood loss for the patient was 80ml.

• Brand Name: CUSTOM 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: 7224562
• MDR Text Key: 98548267
• Report Number: 8030665-2018-00151
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17LR01239
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 160NRE DIALYZER; FRESENIUS 2008T HEMODIALYSIS MACHINE
• Patient Age: 81 YR
• Patient Weight: 64