MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP SAPPHIRE YLW STRIPED+PAV; ELECTRIC INFUSION PUMP ADMINISTRATION SET, SINGLE-USE

Model Number	1637402
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer indicated that the device is available to return for investigation; it has not been received.
Event or Problem Description
The event involved a patient that was receiving bupivacaine 0.2% + fentanyl 2mcg/ml through an epidural that was placed prior to transferring to palliative care.It was noted on (b)(6) 2019, that the epidural bag that was started on (b)(6) 2019 had not seemed to be dispensing the solution.The pump looked to be running the entire time, and the pump never alarmed at any time to indicate there was a problem that it was not dispensing the solution.The drug was intended to be continuously infused throughout the treatment.Upon review, the spike that entered the bag looked to be broken.Pictures provided by the customer show broken pieces of the spike inside the connection port of the bag.The situation resulted in a pain crisis for the patient and required an anesthesia intervention that included an epidural ¿top-up¿ to achieve better pain control.There was a delay in therapy since the patient did not receive the intended treatment until pump was replaced.
Additional Manufacturer Narrative
The date the device was returned to the manufacturer was 12-sept-2019.Received one (1) used 163740455 sapphire set, and one used eva container for testing.The complaint of piercing pin breaking can be confirmed on the returned 163740455 sapphire set.When received the piercing pin of the sapphire set had cold form damage and parts of the tip of the piercing pin was broken off into the nozzle of the eva container.Both the set and the eva container were visually inspected.It was observed that the piercing pin was not fully inserted into the eva container due to the membrane of the nozzle was not fully punctured.The probable cause of the damage observed to the piercing pin is due to unintentional excessive torqueing on the piercing pin that was not fully inserted into the eva container during use.A batch record review was performed to lot# 946365h, list# 16374-0455 and no discrepancies that may have contributed to a complaint of this nature were found.

• Brand Name: NDEHP SAPPHIRE YLW STRIPED+PAV
• Common Device Name: ELECTRIC INFUSION PUMP ADMINISTRATION SET, SINGLE-USE
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8935301
• Report Number: 9615050-2019-00364
• Device Sequence Number: 18944973
• Product Code: MRZ
• UDI-Device Identifier: 10887787007418
• UDI-Public: (01)10887787007418(17)211001(10)946365H
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: 1637402
• Device Catalogue Number: 163740455
• Device Lot Number: 946365H
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUPIVACAINE 0.2% + FENTANYL; SECURE EVA CONTAINER; UNSPECIFIED PUMP; BUPIVACAINE 0.2% + FENTANYL; SECURE EVA CONTAINER; UNSPECIFIED PUMP