MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 1 SAFESET¿, 1 TRANSDUCER 1 PORT, 53 INCH (134 CM), 3ML/ HR MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-0P261-01

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Event Description

The event involved 1 safeset¿, 1 transducer 1 port, 53 inch (134 cm), 3ml/ hr macrodrip which reportedly disconnected/separated during patient use.The nurse reported that the patient was wet in his bed and when the nurse looked up she realized that the arterial catheter was disconnected, even severed, at the level of the tubing connecting the saline bag which is in the counter-pressure bag.There was only saline on the device.There was no observation of mechanical pressure on the device; no tubing was wrapped around the patient.There was a delay in therapy, approximately 20 minutes, but there was no harm reported as a consequence of this event.

Manufacturer Narrative

Additional information sections, a1, a2, a3 and a4.

Manufacturer Narrative

One used partial list #011-0p261-01, 1 safeset¿, 1 transducer 1 port, 53 inch (134 cm), 3ml/ hr macrodrip; lot #5714987 was received for evaluation on 5/26/22.The reported complaint of disconnection was confirmed on the returned set.An image was provided by the customer showing the area of the defect.During visual inspection, the 60" pvc tubing was found separated from the transpac.When the tubing pocket was microscopically examined, spotty adhesive was observed on the tubing.The probable cause of the tubing separation had occurred due to insufficient adhesive coverage on the tubing during manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 1 SAFESET¿, 1 TRANSDUCER 1 PORT, 53 INCH (134 CM), 3ML/ HR MACRODRIP
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14274191
• MDR Text Key: 299576032
• Report Number: 9617594-2022-00106
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619028527
• UDI-Public: (01)00840619028527(17)241101(10)5714987
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2022

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: 011-0P261-01
• Device Lot Number: 5714987
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/10/2022; 06/28/2022
• Supplement Dates FDA Received: 05/26/2022; 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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: SALINE, MFR UNK
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 116 KG