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

Model Number CUSTOM COMBI SET

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 06/08/2018

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 custom combiset's blood lines separated from one another during treatment.They stopped treatment and were not able to return the blood in the line, so about 250cc of blood were lost.The patient did not experience any ill effects or adverse events.The patient was set up with a new set and complete treatment on the same machine.The actual sample is available.

Manufacturer Narrative

Plant investigation: the actual sample was returned to the manufacturer for a physical evaluation.The sample was inspected and was confirmed that there was a separation between the saline priming line and the t connector.No application of solvent was found in the tubing and connector.The device history record [dhr} of this product was reviewed and no nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met specifications.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7613321
• MDR Text Key: 111453641
• Report Number: 8030665-2018-00924
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM COMBI SET
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 18BR01117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 07/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: FRESENIUS HEMODIALYSIS (HD) MACHINE
• Patient Age: 82 YR
• Patient Weight: 80