MAUDE Adverse Event Report: COOPERSURGICAL, INC. INCA

Model Number 44-2709

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow up report will be filed.(b)(4).

Event Description

"multiple patients are becoming disconnected at the inca white adapter where it connects into the circuit.After testing many of the white adapters, fitment is different on each one.Some fit tightly, some are extremely loose, and some fit tightly on one side of the adapter and loosely on the other side of the adapter when flipped around.Our nicu rt staff has been having some issues with the inca interface.(b)(4) has been a long-time user of incas and we have recently seen issues with the connection from the inca interface to the circuit.This connection becomes loose, causing the patient to become disconnected from the circuit, creating serious patient safety issues." (b)(4).

Event Description

"multiple patients are becoming disconnected at the inca white adapter where it connects into the circuit.After testing many of the white adapters, fitment is different on each one.Some fit tightly, some are extremely loose, and some fit tightly on one side of the adapter and loosely on the other side of the adapter when flipped around.Our nicu rt staff has been having some issues with the inca interface.Ucmc has been a long-time user of incas and we have recently seen issues with the connection from the inca interface to the circuit.This connection becomes loose, causing the patient to become disconnected from the circuit, creating serious patient safety issues." ref e-complaint-(b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation, x-review dhr, x-inspect returned samples and x-inspect stock product.Analysis and findings: the root cause for the reported complaint event cannot be determined as all samples returned were visually verified to be compliant and complete per csi work instruction requirements.A review of the two-year complaint history indicated that there were other similar complaints previously reported.Based on past similar reported event analysis investigations, it was determined that the root cause was likely due to the incompatibility of the semi translucent reducer adapter (rt064) used by the end user to mate or attach it to the csi white end connector.The reducer adapter that was returned with the inca kits is not supplied or provided by csi inc.A review of the csi manufacturing assembly instructions indicated that nothing had been changed, and work instructions were properly being followed and adhered to.Further verification of the white adapter mentioned in the complaint, part number 010-013, was performed in the way of a dimensional verification which found it to be within print tolerances.In addition, sk warehouse inventory was also sampled and found acceptable.Component has been removed form dts (dock to stock), so that future receipts may be sampled and verified by csi incoming inspection.A dimensional verification of the semi translucent adapter (not provided or available with csi inc.Inca kit) was also performed, and although on the reduced end it has a.016 interference fit, it is tapered and is not enough to ensure a continuous attached state.A review of the lot dhr for work order (b)(4) was performed and found to be acceptable without any abnormalities.Correction and/or corrective action: none.Reason: corrective action is not applicable as all returned product was verified to be compliant in the kit contents and found dimensionally acceptable.Was the complaint confirmed? no.This complaint will be monitored for trending to access potential future action.Preventative action activity: add warning to ifu to verify compatibility with adapters not supplied with oem system.Reference e-complaint-(b)(4).

• Brand Name: INCA
• Type of Device: INCA
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8290424
• MDR Text Key: 134749626
• Report Number: 1216677-2019-00015
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K911780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/11/2020
• Device Model Number: 44-2709
• Device Catalogue Number: 44-2709
• Device Lot Number: 233701
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other