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

Catalog Number 03-2522-1

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A facility administrator (fa) reported to fresenius that the registered nurse (rn) tried to pull a blood sample from the injection site and the port did not seal when the needle was removed resulting in blood that pumped "all over" the rn and the patient.The lines coming from the dialyzer kinked preventing the dialyzer from being flipped to remove air and the clamps were not strong enough to stay closed.Air entered the circuit which prevented the patient's blood from being returned.The patient's estimated blood loss (ebl) is approximately 300 ml.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.Treatment was successfully completed on the same machine after replacing the supplies.It was reported the sample was discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Event Description

A facility administrator (fa) reported to fresenius that the registered nurse (rn) tried to pull a blood sample from the injection site and the port did not seal when the needle was removed resulting in blood that pumped "all over" the rn and the patient.The lines coming from the dialyzer kinked preventing the dialyzer from being flipped to remove air and the clamps were not strong enough to stay closed.Air entered the circuit which prevented the patient's blood from being returned.The patient's estimated blood loss (ebl) is approximately 300 ml.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.Treatment was successfully completed on the same machine after replacing the supplies.It was reported the sample was discarded and is not available to be returned to the manufacturer for physical evaluation.

• Brand Name: COMBISET BLOODLINE
• 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.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18210138
• MDR Text Key: 329025252
• Report Number: 0008030665-2023-01080
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861102402
• UDI-Public: 00840861102402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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 Catalogue Number: 03-2522-1
• Device Lot Number: 23LR01804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• 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 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Sex: Male